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Clinical Toxicology (TX) FDA Submissions

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

CFR Parts: Part 862

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
LDPColorimetry, Acetaminophen862.3030236
KLPAmikacin Serum Assay862.303524
KLQRadioimmunoassay, Amikacin862.3035220
LDNEnzymatic Radiochemical Assay, Amikacin862.303523
LGJFluorescence Polarization Immunoassay, Amibacin862.303523
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method862.3040233
DIZDelayed Analysis, Alcohol862.304020
DLATest Reagents For Methyl Alcohol862.304020
DLHGas Chromatography, Alcohol862.304020
DLSGas Chromatograph, Alcohol (Dedicated Instruments)862.304020
DMIPotassium Dichromate Specific Reagent For Alcohol862.304021
DMJTest Reagents For Ethyl Alcohol862.304020
DMLNad-Nadh, Specific Reagent For Alcohol Enzyme Method862.3040213
DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet862.304028
DOJPotassium Dichromate, Alcohol862.304022
OICBlood Alcohol Kit (Excludes Hiv Testing)862.304020
ORABreast Milk-Alcohol Test System862.304020
DJZDevices, Breath Trapping, Alcohol862.3050128
MXASystem, Test, Breath Nitric Oxide862.3080215
DITThin Layer Chromatography, Amphetamine862.310024
DJLFree Radical Assay, Amphetamine862.310020
DJPRadioimmunoassay, Amphetamine862.310029
DKZEnzyme Immunoassay, Amphetamine862.31002225
DNILiquid Chromatography, Amphetamine862.310021
DODGas Chromatography, Amphetamine862.310021
DPJRadioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.862.310022
NFTTest, Amphetamine, Over The Counter862.3100228
NVIDiagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease862.310021
OIWSoftware, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types862.310024
PUXTest, Amphetamine, Employment And Insurance Testing, Exempt862.310020
DNEAtomic Absorption, Antimony862.311010
QXTInfliximab Test System862.311521
QYDAdalimumab Assay862.311521
DNZAtomic Absorption, Arsenic862.312010
DISEnzyme Immunoassay, Barbiturate862.31502100
DJNMercury Dithiazone, Colorimetry, Barbiturate862.315021
DKNRadioimmunoassay, Barbiturate862.315024
DKXThin Layer Chromatography, Barbiturate862.315022
DLXHemagglutination Inhibition, Barbiturate862.315020
DMFGas Liquid Chromatography, Barbiturate862.315020
KZYHigh Pressure Liquid Chromatography, Barbiturate862.315020
PTHTest, Barbiturate, Over The Counter862.315021
PUYTest, Barbiturate, Employment And Insurance Testing, Exempt862.315020
JXMEnzyme Immunoassay, Benzodiazepine862.3170290
KZZGas Chromatography, Benzodiazepine862.317020
LAAHigh Pressure Liquid Chromatography, Benzodiazepine862.317021
LABThin Layer Chromatography, Benzodiazepine862.317020
NFVTest, Benzodiazepine, Over The Counter862.317020
PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt862.317020
DKBCalibrators, Drug Mixture862.3200294
DLJCalibrators, Drug Specific862.32002123
DNNCalibrators, Ethyl Alcohol862.320027
JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide862.322018
JKTGas Chromatograph, Carbon-Monoxide862.322012
MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites862.322017
MRSTest System, Nicotine, Cotinine, Metabolites862.322013
DIGCholinesterase Test Paper862.324011
DIHColorimetry, Cholinesterase862.3240126
DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase862.324016
DMRSolution, M-Nitrophenol, Specific Reagent For Cholinesterase862.324011
DOHElectrometry, Cholinesterase862.324010
DINGas Chromatography, Cocaine862.325020
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites862.32502145
DIRFree Radical Assay, Cocaine862.325021
DLNHemagglutination, Cocaine Metabolites (Benzoylecgnonine)862.325024
DMNThin Layer Chromatography, Cocaine862.325022
DNGFree Radical, Benzoylecgnonine862.325020
DOMThin Layer Chromatography, Benzoylecgnonine862.325020
JXOEnzyme Immunoassay, Cocaine862.325026
KLNRadioimmunoassay, Cocaine Metabolite862.3250214
LACHigh Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites862.325020
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter862.325020
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt862.325020
DLDThin Layer Chromatography, Codeine862.327020
LADGas Chromatography, Codeine862.327020
LAEHigh Pressure Liquid Chromatography, Codeine862.327022
PVBTest, Codeine, Employment And Insurance Testing, Exempt862.327020
DIEHeavy Metals Control Materials862.328015
DIFDrug Mixture Control Materials862.32801202
DJKDigitoxin Control Serum, Ria862.328011
DKCAlcohol Control Materials862.3280111
DMPDigoxin Control Serum, Ria862.328014
LASDrug Specific Control Materials862.3280183
LAWTheophylline Control Materials862.328014
LAXLidocaine Control Materials862.328011
LAYMethotrexate Control Materials862.328010
LAZN-Acetylprocainamide Control Materials862.328014
LBAProcainamide Control Materials862.328011
DKQAntiserum, Digitoxin862.330020
DNDRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.862.330021
DNWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.862.330020
DOBRadioimmunoassay, Digitoxin (3-H)862.330020
DOWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube862.330020
DPGRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.862.330023
DPLRadioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.862.330020
LCWRadioimmunoassay, Digitoxin (125-I)862.330023
LFMEnzyme Immunoassay, Digitoxin862.3300220
DKAAntiserum, Digoxin862.332023
DNJRadioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.862.332022
DNLRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.862.332028
DNQRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.862.332020
DNSRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.862.332020
DOARadioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.862.332021
DOGRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol862.332025
DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.862.3320217
DORRadioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.862.332021
DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.862.332025
DPBRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.862.3320210
DPDRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.862.332021
DPIRadioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.862.332020
DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.862.3320214
KXTEnzyme Immunoassay, Digoxin862.3320285
LANEnzyme Immunoassay, N-Acetylprocainamide862.3320221
LAREnzyme Immunoassay, Procainamide862.3320225
LBZEnzyme Immunoassay, Quinidine862.3320227
LCSRadioimmunoassay, Digoxin (125-I)862.3320215
LCTRadioimmunoassay, Digoxin (3-H)862.332020
DIPEnzyme Immunoassay, Diphenylhydantoin862.3350244
DKHGas Chromatography, Diphenylhydantoin862.335022
DLPRadioimmunoassay, Diphenylhydantoin862.335025
DOZLiquid Chromatography, Diphenylhydantoin862.335021
DPEThin Layer Chromatography, Diphenylhydantoin862.335021
LDCU.V. Spectrometry, Diphenylhydantoin862.335020
LESFluorescent Immunoassay, Diphenylhydantoin862.335027
LFONephelometric Inhibition Immunoassay, Diphenylhydantoin862.335021
LGRFluorescence Polarization Immunoassay, Diphenylhydantoin (Total)862.3350215
MOJFluorescence Polarization Immunoassay, Diphenylhydantoin (Free)862.335023
MSLSystem, Test, Topiramatee862.335021
NWMImmunoassay, Anti-Seizure Drug862.335025
ORHLamotrigine Assay862.335022
ORILevetiracetam Assay862.335022
OTFGabapentin Assay862.335021
NTIDrug Metabolizing Enzyme Genotyping Systems862.3360211
ODWCytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System862.336026
DIYGas Chromatography, Ethosuximide862.338021
DJXRadioimmunoassay, Ethosuximide862.338020
DLFEnzyme Immunoassay, Ethosuximide862.338029
DNFLiquid Chromatography, Ethosuximide862.338020
DNPThin Layer Chromatography, Ethosuximide862.338021
DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.862.3450219
DJIAntiserum, Gentamicin862.345021
DKDBacillus Subtilis, Microbiological Assay, Gentamicin862.345022
DNOHemagglutination Inhibition, Gentamicin862.345021
KLOEnzymatic Radiochemical Assay, Gentamicin862.345020
KZTKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin862.345021
LCDEnzyme Immunoassay, Gentamicin862.3450237
LCERadioimmunoassay, Netilmicin (I-125)862.345026
LCQFluorescent Immunoassay Gentamicin862.3450219
QDRPlazomicin Test System, Immunoassay862.346021
KJIRadioimmunoassay, Kanamycin862.352026
KZWKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin862.352020
DIJLead, Delta Amino Levulinic Acid862.355022
DMKLead, Protoporphyrin, Fluorometric862.355020
DNXLead, Protoporphyrin Zinc Method, Fluorometric862.355020
DOFLead, Atomic Absorption862.355026
DOXFluorometer, Lead (Dedicated Instruments)862.355024
KLREnzyme Immunoassay, Lidocaine862.3555217
JIHFlame Photometry, Lithium862.3560212
JIIAtomic Absorption, Lithium862.356023
NDWAssay, Porphyrin, Spectrophotometry, Lithium862.356027
DLBRadioimmunoassay, Lsd (125-I)862.358027
DOLFree Radical Assay, Lsd862.358020
PVCTest, Lsd, Employment And Insurance Testing, Exempt862.358020
QBKMeprobamate Test System862.359022
DPHMercury, Atomic Absorption862.360012
DJCThin Layer Chromatography, Methamphetamine862.3610231
LAFGas Chromatography, Methamphetamine862.3610249
LAGHigh Pressure Liquid Chromatography, Methamphetamine862.361024
NGGTest, Methamphetamine, Over The Counter862.361021
PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt862.361020
DIWHemagglutination Inhibition, Methadone862.362024
DJREnzyme Immunoassay, Methadone862.3620263
DKRThin Layer Chromatography, Methadone862.362020
DMBGas Chromatography, Methadone862.362021
DNTLiquid Chromatography, Methadone862.362020
DPPFree Radical Assay, Methadone862.362020
PTGTest, Methadone, Over The Counter862.362020
PVETest, Methadone, Employment And Insurance Testing, Exempt862.362020
KXSRadioimmunoassay, Methaqualone862.3630216
PVFTest, Methaqualone, Employment And Insurance Testing, Exempt862.363020
DIQRadioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.862.364020
DJJFluorometry, Morphine862.364021
DLRHemagglutination Inhibition, Morphine862.364022
DMYGas Chromatography, Morphine862.364021
DNARadioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody862.364020
DNKThin Layer Chromatography, Morphine862.364024
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.862.3640212
DOKFree Radical Assay, Morphine862.364021
DPKLiquid Chromatography, Morphine862.364022
NGITest, Morphine, Over The Counter862.364020
PVGTest, Morphine, Employment And Insurance Testing, Exempt862.364020
DLEReagents, Test, Bromides862.364520
JKQGold Chloride (Colorimetric), Bromide862.364520
KLTEnzyme Immunoassay, Carbamazepine862.3645256
LDBU.V. Spectrometry, Carbamazepine862.364520
LEGEnzyme Immunoassay, Valproic Acid862.3645235
LGIFluorescence Polarization Immunoassay, Carbamazepine862.364523
LPXRadioceptor Assay, Neuroleptic Drugs862.364520
POXEnzyme Immunoassay, Oxcarbazepine Metabolite862.364521
DJFGas Chromatography, Opiates862.365020
DJGEnzyme Immunoassay, Opiates862.36502215
DKTFree Radical Assay, Opiates862.365020
DLTHemagglutination, Opiates862.365021
LAHHigh Pressure Liquid Chromatography, Opiates862.365020
LAIThin Layer Chromatography, Opiates862.365021
NGLTest, Opiates, Over The Counter862.3650223
PVHTest, Opiates, Employment And Insurance Testing, Exempt862.365020
PDYOrganophosphate Test System862.365221
DIXThin Layer Chromatography, Phenobarbital862.366020
DJHGas Chromatography, Phenobarbital862.366021
DKPRadioimmunoassay, Phenobarbital862.366023
DLZEnzyme Immunoassay, Phenobarbital862.3660235
DOOLiquid Chromatography, Phenobarbital862.366020
LDAU.V. Spectrometry, Phenobarbital862.366020
LETFluorescent Immunoassay, Phenobarbital862.366028
LFNNephelometric Inhibition Immunoassay, Phenobarbital862.366025
LGQFluorescence Polarization Immunoassay, Phenobarbital862.3660212
DJQTest Reagents For Phenothiazine862.367021
DILRadioimmunoassay, Primidone862.368020
DJDEnzyme Immunoassay, Primidone862.368028
DMQGas Chromatography, Primidone862.368020
DOSThin Layer Chromatography, Primidone862.368020
DPQLiquid Chromatography, Primidone862.368020
LCZU.V. Spectrometry, Primidone862.368020
LFTFluorescent Immunoassay, Primidone862.368028
DPNThin Layer Chromatography, Propoxyphene862.370021
JXNEnzyme Immunoassay, Propoxyphene862.3700222
LAJGas Chromatography, Propoxyphene862.370020
LAKHigh Pressure Liquid Chromatography, Propoxyphene862.370020
PVITest, Propoxyphene, Employment And Insurance Testing, Exempt862.370020
QBFTest, Propoxyphene, Over The Counter862.370021
DIKThin Layer Chromatography, Quinine862.375010
LALEas Chromatography, Quinine862.375010
LAMHigh Pressure Liquid Chromatography, Quinine862.375010
DIMGas Chromatography, Salicylate862.383020
DJEThin Layer Chromatography, Salicylate862.383021
DKJColorimetry, Salicylate862.3830229
DMXLiquid Chromatography, Salicylate862.383020
DNCStrip, Paper, Salicylate862.383020
NRPSirolimus Test System862.384025
OAVMycophenolic Acid Test System862.384023
OUFEverolimus Immunoassay862.384022
DKWTest Reagents For Sulphanimide Derivatives862.385010
DKEReagents, Test, Tetrahydrocannabinol862.3870212
LATRadioimmunoassay, Cannabinoid(S)862.3870216
LDJEnzyme Immunoassay, Cannabinoids862.38702151
NFWTest, Cannabinoid, Over The Counter862.387024
PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt862.387020
KLSEnzyme Immunoassay, Theophylline862.3880271
LCARadioimmunoassay, Theophylline862.388025
LCYU.V. Spectrometry, Theophylline862.388023
LERFluorescent Immunoassay, Theophylline862.3880215
LEWThin Layer Chromatography, Theophylline862.388021
LGSFluorescence Polarization Immunoassay, Theophylline862.3880213
DIDBacillus Subtilis Microbiology Assay, Tobramycin862.390025
KLBRadioimmunoassay, Tobramycin862.3900223
KZXKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin862.390020
LCRFluorescent Immunoassay, Tobramycin862.3900217
LDOEnzymatic Radiochemical Assay, Tobramycin862.390023
LFWFluorescence Polarization Immunoassay, Tobramycin862.3900210
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs862.3910221
LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs862.391026
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs862.391024
MLKThin Layer Chromatography, Tricyclic Antidepressant Drugs862.391022
PVKTest, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt862.391020
QAWTest, Tricyclic Antidepressants, Over The Counter862.391020
LEHRadioimmunoassay, Vancomycin862.3950231
PUJVoriconazole Test System862.397021
Innolitics

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