FDA Device Explorer

Hematology (HE) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Hematology (HE) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 660, Part 864

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
QHRBlood Grouping Reagent660.20U0
QHTReagent Red Blood Cells660.30U0
QHSAnti-Human Globulin660.50U0
GGHIron Stains864.185011
GHZSolution, Gugol Blue864.185010
GJHStain, Reticulocyte864.185011
GJJStains, Heinz Body864.185010
GJLRomanowsky Stains864.185011
HYBEosin Y864.1850110
HYCFast Green864.185011
HYDFast Red Salt B864.185011
HYESolution, Fontanna Silver864.185010
HYFGiemsa Stain864.185014
HYGGlenner'S Stain864.185011
HYHGold Chloride864.185010
HYIIodine, Grams864.185016
HYJHematoxylin864.1850114
HYKHematoxylin Harris'S864.185017
HYLHematoxylin Mayer'S864.185010
HYOHematoxylin Weigert'S864.185011
HYQIron Chloride-Weigert864.185010
HYRLeuco-Patent Blue864.185010
HYSLight Green864.185011
HYTLuxol Fast Blue864.185010
HYWStain, Trichrome, Mallory'S864.185012
HYYMetanil Yellow864.185010
HYZMethenamine Silver864.185010
HZAMethyl Green864.185012
HZCMucicarmine864.185012
HZDMuller'S Colloidal Iron864.185010
HZENile Blue864.185010
HZFNuclear Fast Red864.185010
HZGOil Red O864.185011
HZHOrange G864.185014
HZJStain, Papanicolau864.1850115
HZLPhloxine B864.185011
HZMHematoxylin, Acid, Phosphotungstic864.185010
HZNPicro Methyl Blue864.185010
HZOStain, Ponceau864.185011
HZPPyronin864.185010
HZQRed-Violet Lb864.185010
HZRResorcin Fuchsin864.185010
HZSSafranin864.185011
HZTReagent, Schiff864.185015
HZXSilver Nitrate864.185010
HZYSirius Red864.185010
HZZSudan Black B864.185012
IAATitan Yellow864.185010
IABToluidine Blue864.185011
IACVan Gieson'S Stain864.185011
IADVan Gieson'S Picro-Fuchsin864.185010
IAEHematoxylin, Iron, Weigert'S864.185011
IAFWright'S Stain864.1850133
ICCEosin B864.185011
ICDDarrow Red864.185010
ICFCrystal Violet For Histology864.185015
ICGCresyl Violet Acetate864.185010
ICHCongo Red864.185011
ICIHematoxylin, Chrome Alum864.185010
ICJCarbol Night Blue864.185011
ICLCarbol Fuchsin864.185014
ICMBrilliant Yellow864.185010
ICNBiebrich Scarlet864.185012
ICOBest'S Carmine864.185010
ICQAzure A864.185010
ICRAzocarmine B864.185010
ICSAzocarmine G864.185010
ICTAzan Counterstain864.185010
ICXAniline864.185011
ICYAcid, Aniline, Fuchsin864.185010
ICZAmmoniacal Silver Hydroxide Silver Nitrate864.185010
IDAAlcian Blue864.185012
IDBAldehyde Fuchsin864.185010
IDCAcridine Orange864.185014
IDDAlizarin Red864.185010
IDEAcid, Hematein864.185010
IDFAcid, Fuchsin864.185011
JCHEsterase864.185010
JCIAcid Phosphatase, Cytochemical864.185010
JTSStains, Microbiologic864.1850140
KFCMethylene Blue, Tissue Stain864.185017
KFDAniline Blue864.185011
KFENeutral Red864.185011
KJKAuramine O864.185012
KJLAzure C864.185010
KJMBismarck Brown Y864.185010
KJNBrilliant Cresyl Blue864.185011
KJOBrilliant Green864.185010
KJPCarmine864.185010
KJQChlorazol Black E864.185010
KJRErythrosin B864.185013
KJSEthyl Eosin864.185010
KJTIndigocarmine864.185010
KJWJanus Green B864.185010
KJXJenner Stain864.185011
KJYMalachite Green864.185011
KJZMartius Yellow864.185010
KKAMethyl Orange864.185010
KKBMethyl Violet 2b864.185010
KKCMethylene Violet864.185010
KKDNigrosin864.185010
KKEOrange Ii864.185010
KKFOrcein864.185010
KKGProtargol S864.185010
KKHTablet, Resazurin864.185010
KKIRose Bengal864.185010
KKJSudan Iii864.185011
KKKSudan Iv864.185011
KKLThionin864.185010
KKMMethylene Blue Thiocyanate864.185010
KKPSolution, Silver Carbonate864.185010
KKQSodium Periodate864.185010
KKRPotassium Periodate864.185010
KKSAcid, Periodic864.185010
KKTHematoxylin, Ehrlich'S864.185010
KKWBasic Fuchsin864.185010
KQCStains, Hematology864.185019
LEDStains, Chemical Solution864.1850116
LEEStains, Dye Solution864.185011
LEFStains, Dye Powder864.185011
LGYTrypan Blue864.185011
LPIKit, Assay, Progesterone Receptor864.186034
LPJKit, Assay, Estrogen Receptor864.186034
MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor864.1860213
MYAImmunohistochemistry Antibody Assay, Estrogen Receptor864.1860212
NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer864.186021
NJTImmunohistochemistry Reagents And Kits864.186010
NJWControl Material, Her-2/Neu, Immunohistochemistry864.186022
NKFImmunohistochemistry Antibody Assay, C-Kit864.186032
NOTMicroscope, Automated, Image Analysis, Operator Intervention864.1860212
NQFImmunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor864.186031
NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity864.1860215
NTRImmunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells864.186011
OEOAutomated Digital Image Manual Interpretation Microscope864.186026
QKFImmunocytochemistry Assay, P16/Ki-67864.186031
QNHImmunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay864.186033
QULImmunohistochemistry Assay, Antibody, Folr1864.186031
QZJImmunohistochemistry Assay, Antibody, Claudin 18864.186031
SBLImmunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4864.186031
SERImmunohistochemistry Assay, Antibody, Met864.186031
SDPKappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit864.186121
PDOEarly Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization864.187021
PFGDna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders864.187021
KITMedia And Components, Synthetic Cell And Tissue Culture864.22201367
KIYChamber, Slide Culture864.224011
KIZDish, Tissue Culture864.224018
KJAFlask, Tissue Culture864.2240113
KJBApparatus, Roller864.224013
KJCBottle, Roller, Tissue Culture864.224013
KJDSpinner, Flask864.224010
KJESpinner System, Cell Culture864.224010
KJFSystem, Suspension, Cell Culture864.224014
KJHApparatus, Perfusion864.224013
NVGTissue Culture, Accessories, Dental864.224010
KIQKit, Culture, Chromosome864.226011
KIRCells, Animal And Human, Cultured864.22801170
KIWKit, Mycoplasma Detection864.236012
KIXMedia, Mycoplasma Detection864.236010
KPBMedia And Components, Mycoplasma Detection864.236014
KISSera, Animal And Human864.2800145
KIPFormulations, Balanced Salt Solutions864.2875117
SFSRevumenib Eligibility Detection System864.188521
GKLCounter, Cell, Automated (Particle Counter)864.52002130
GKXInstrument, Automated Platelet Counting864.520022
LKMCounter, Urine Particle864.5200215
GKZCounter, Differential Cell864.52202379
LIZAssay, T Lymphocyte Surface Marker864.522027
LJDAssay, B Lymphocyte Marker864.522021
MAMDna-Probe, B And T Lymphocyte864.522022
NIDAssay, Proliferation, In Vitro, T Lymphocyte864.522022
OYEFlow Cytometric Reagents And Accessories.864.522028
PDXFlow Cytometry Calibrator864.522020
PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System864.522021
POVSemen Analysis Device864.5220228
GKHApparatus, Automated Blood Cell Diluting864.5240114
JOYDevice, Automated Cell-Locating864.5260235
LNJAnalyzer, Chromosome, Automated864.5260211
SALDevice, Automated Cell Locating, Bone Marrow864.526121
JBWRed-Cell Indices, Measured864.530020
JPJRed-Cell Indices, Calculated864.530023
KQHRed-Cell Indices864.530021
GHKCentrifuge, Microsedimentation864.535010
GIEFibrometer864.540022
GKNTimer, Clot, Automated864.540023
GKPInstrument, Coagulation, Automated864.5400249
JBTTimer, Coagulation864.540020
KQGInstrument, Coagulation864.5400214
GGCControl, Plasma, Abnormal864.5425240
GGNPlasma, Coagulation Control864.5425299
GIZPlasma, Control, Normal864.5425220
JPASystem, Multipurpose For In Vitro Coagulation Studies864.54252180
LGPAssay, Alpha-2-Antiplasmin864.542525
LLGKit, Igg, Platelet Associated864.542522
QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties864.543028
GKFInstrument, Hematocrit, Automated864.5600215
GKRSystem, Hemoglobin, Automated864.5620239
JOXAnalyzer, Heparin, Automated864.5680215
GHRReagent, Platelet Aggregation864.5700211
JOZSystem, Automated Platelet Aggregation864.5700238
OBW11-Dehydro Thromboxane B2 Kit, Urinary864.570021
GKBDevice, Automated Sedimentation Rate864.580012
GKJSpinner, Slide, Automated864.585016
JWODevice, Blood Volume Measuring864.595022
JCADevice, Bleeding Time864.610027
GIOTube, Collection, Capillary Blood864.6150122
GGXPipette, Sahli864.616012
GGYPipette, Diluting864.616010
GHOHemocytometer864.616012
GJGPipette, Quantitative, Hematology864.616014
GJWPipette, Pasteur864.616014
GKMHand-Tally, Differential864.616014
GLGPlatelet Counting, Manual864.616013
GHYHematocrit, Tube, Rack, Sealer, Holder864.640022
GKGCentrifuge, Hematocrit864.6400211
JPIDevice, Hematocrit Measuring864.6400215
GGGGuaiac Reagent864.655021
JIOBlood, Occult, Colorimetric, In Urine864.6550211
JIPBlood, Occult, Enzymatic Method, In Urine864.655020
KHEReagent, Occult Blood864.6550297
NGKTest, Occult Blood, Over The Counter864.655020
OOXAutomated Occult Blood Analyzer864.655026
OSLControl, Fecal Occult Blood864.655021
GKEOsmotic Fragility Testing864.660010
JBZStudy, Platelet Adhesive864.665023
GKWAggregometer, Platelet, Thrombokinetogram864.667520
JBXAggregrometer, Platelet864.6675212
JBYAggregometer, Platelet, Photo-Optical Scanning864.667522
GHCTube, Sedimentation Rate864.670011
JPHTest, Erythrocyte Sedimentation Rate864.670017
PWDFlow Cytometric Test System For Hematopoietic Neoplasms864.701022
JWRAtp Release (Luminescence)864.704010
KHFAdenine Nucleotide Quantitation864.704010
DDQAntigen, Antiserum, Control, Antithrombin Iii864.706024
JBQAntithrombin Iii Quantitation864.7060256
JPEAntithrombin Iii, Two Stage Clotting Time Assay864.706021
JBECell Enzymes (Erythrocytic And Leukocytic)864.710021
LKZRed-Cell Count By Photometry864.710022
JBPActivated Whole Blood Clotting Time864.7140224
GGTAssay, Erythropoietin864.7250220
JBOTest, Euglobulin Lysis864.727521
NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr864.728026
NPRTest, Factor Ii G20210a Mutations, Genomic Dna Pcr864.728025
OMMTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr864.728022
PHJSystem, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations864.728021
GGPTest, Qualitative And Quantitative Factor Deficiency864.72902190
GJTPlasma, Coagulation Factor Deficient864.7290279
QTYVon Willebrand Factor Assay864.729321
QLUAnti-Factor Xa Activity Test System, Apixaban864.729523
SACAdamts13 Activity Test System864.729721
SESNon-Factor Replacement Product Test System864.729821
JBNFibrin Monomer Paracoagulation864.730022
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control864.7320257
GHHFibrin Split Products864.7320228
MIFProthrombin Fragment 1.2864.732026
DARFibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control864.734020
DATFibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control864.734022
DAXFibrinogen And Split Products, Fitc, Antigen, Antiserum, Control864.734020
DAZFibrinogen And Split Products, Antigen, Antiserum, Control864.734020
GFKFibrinogen Determination Standards And Controls864.734021
GFXFibrinogen Standard864.734023
GILPlasma, Fibrinogen Control864.734028
GISTest, Fibrinogen864.7340213
KQJSystem, Fibrinogen Determination864.7340228
JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening864.736025
JBGGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot864.736020
JBHGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod864.736020
JBIGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition864.736020
JBJGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction864.736020
JBKGlucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic864.736020
JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative864.736022
JBMGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis864.736020
JLMIsoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase864.736021
JMBVisual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase864.736021
JMCNadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase864.736020
KQEAssay, Erythrocytic Glucose-6-Phosphate Dehydrogenase864.736021
GIIGlutathione, Red-Cell864.737520
JMHFluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase864.737520
KQFAssay, Glutathione Reductase864.737520
JPDHemoglobin A2 Quantitation864.7400213
GIQHemoglobin S864.741523
GKAAbnormal Hemoglobin Quantitation864.7415223
JCMControl, Hemoglobin, Abnormal864.7415212
JPBHemoglobin M864.741520
MLLHemoglobin C (Abnormal Hemoglobin Variant)864.741521
GHSAssay, Carboxyhemoglobin864.742525
JBDSystem, Analysis, Electrophoretic Hemoglobin864.7440226
GHAHemoglobin, Alkali Resistant864.745520
GHQStain, Fetal Hemoglobin864.745522
JPCHemoglobin F Quantitation864.745521
KQIAssay, Fetal Hemoglobin864.745524
LIMTest, Screening, For D Positive Fetal Rbc'S864.745522
LCPAssay, Glycosylated Hemoglobin864.74702249
NGBTest, Glycosylated Hemoglobin, Over The Counter864.747020
NOZAssay, 1,5-Anhydroglucitol (15ag)864.747022
GJCAssay, Sulfhemoglobin864.749020
GGFAcid Hematin864.750020
GGZOxyhemoglobin864.750022
GIGHemoglobinometer864.750023
GJZCyanomethemoglobin Reagent And Standard Solution864.750022
GKKCyanomethemoglobin864.750027
GLYOximeter To Measure Hemoglobin864.750025
KHGWhole Blood Hemoglobin Determination864.7500239
LGLAssay, Bart'S, Hemoglobin864.750022
QGUHemoglobin For Donor Testing864.750020
GFTProtamine Sulphate864.752522
JBRTest, Heparin Neutralization864.752523
KFFAssay, Heparin864.7525246
GHDTest, Leukocyte Alkaline Phosphatase864.766014
JCJAlkaline Phosphatase864.766010
GIATest, Leukocyte Peroxidase864.767513
LGOTest, Leukocyte Typing864.767515
LJXTest, Urine Leukocyte864.767517
LCOPlatelet Factor 4 Radioimmunoassay864.7695213
GGQTest, Prothrombin Consumption864.772022
JPFProthrombin-Proconvertin And Thrombotest864.773520
GJSTest, Time, Prothrombin864.77502127
ODVVitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System864.775021
GHMTest, Sickle Cell864.7825218
JBBSolubility, Hemoglobin, Abnormal864.782522
GJATest, Thrombin Time864.7875220
GJBThrombin864.787521
GKQTest, Thromboplastin Generation864.790011
GFOActivated Partial Thromboplastin864.7925252
GGOReagent, Thromboplastin And Control864.792521
GGWTest, Time, Partial Thromboplastin864.7925232
GITReagent & Control, Partial Thromboplastin Time864.792524
JCOBothrops Atrox Reagent864.810027
KRXCalibrator For Cell Indices864.8150216
KRZCalibrator For Hemoglobin And Hematocrit Measurement864.8165225
KRYCalibrator For Platelet Counting864.817528
KSACalibrator For Red-Cell And White-Cell Counting864.818528
GGJFluid, Diluting, White-Cell864.820011
GIFDiluent, Blood Cell864.8200138
GJNFluid, Diluting, Red-Cell864.820010
JCGFluid, Diluting, Manual Cell864.820011
JCFLymphocyte Separation Medium864.8500112
GGKProducts, Red-Cell Lysing Products864.8540129
GFSStandards And Controls, Hemoglobin, Normal And Abnormal864.862521
GGLControl, White-Cell864.862528
GGMControl, Hemoglobin864.8625215
GJPControl, Platelet864.862524
GJRControl, Red-Cell864.862525
GLKControl, Hematocrit864.862527
GLQMixture, Control, White-Cell And Red-Cell Indices864.8625210
JCNControl, Cell Counter, Normal And Abnormal864.8625212
JPKMixture, Hematology Quality Control864.86252192
MZGTest, Residual, Wbc In Leukoreduced Blood864.862520
NRFMaterial, Quality Control, Semen Analysis864.862523
NRSControl Material, Blood Circulating Epithelial Cancer Cell864.862521
GIRReagent, Russel Viper Venom864.8950116
KSSSupplies, Blood-Bank864.905016
KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components864.9100216
QYCContainer System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions864.911520
KSTSystem, Blood Collection, Vacuum-Assisted, Manual864.912510
MYXSystem, Blood Collection, Vacuum-Assisted, Automated864.912510
KSWSystem, Processing For Frozen Blood864.914521
KSXSubstance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use864.916028
MMHBlood Establishment Computer Software And Accessories864.916520
KSZSystem, Test, Automated Blood Grouping And Antibody864.917524
OQXSelf-Contained Blood Grouping 864.917520
PBCManual Blood Grouping And Antibody Test Systems864.917520
KSYBoxes, View, Blood Grouping864.918511
KSQDevice, Blood Mixing And Blood Weighing864.919518
MYJDevice, Mixing And Weighing, Semi-Automated864.919520
BSAWarmer, Blood, Electromagnetic Radiation864.920530
BSBWarmer, Blood, Non-Electromagnetic Radiation864.9205214
KZLDevice, Warming. Blood And Plasma864.920524
KSPApparatus, Cell-Freezing And Reagents864.922511
GKTSeparator, Automated, Blood Cell, Diagnostic864.9245210
ORGPlatelet And Plasma Separator For Bone Graft Handling864.924520
PKGBone Marrow Processing Device To Support Hematopoietic Reconstitution864.924520
PMQPeripheral Blood Processing Device For Wound Management864.924520
KSOCentrifuge, Blood-Bank For In Vitro Diagnostic Use864.927511
KSNCentrifuge, Cell-Washing, Automated For Immuno-Hematology864.928521
KSMSystem, Test, Combs, Automated864.930020
KSLSolution, Copper Sulfate For Specific Gravity Determinations864.932012
KSKSolution, Stabilized Enzyme864.940025
KSILectins And Protectins864.955024
KSHChamber, Environmental For The Storage Of Platelet Concentrate864.957520
KSGMedia, Potentiating For In Vitro Diagnostic Use864.9600213
KSFKit, Quality Control For Blood Banking Reagents864.9650212
PFKQuality Control For Molecular Immunohematology Tests864.965020
KSERefrigerator, Freezer, Blood Storage864.970024
KSDDevice, Heat-Sealing864.975011
KSBSet, Transfer (Blood/Plasma)864.987526
OAOCord Blood Processing System And Storage Container864.990020
OOFCryogenic Cord Blood Storage Container864.990020
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