Pathology (PA) FDA Submissions
Browse FDA 510(k), De Novo, and PMA medical device clearances for the Pathology (PA) review panel, including product codes, regulations, and cleared devices.
CFR Parts: Part 864, Part 866
Subparts
- Part 864 Subpart B—Biological Stains — 1 product code
- Part 864 Subpart D—Pathology Instrumentation and Accessories — 57 product codes
- De Novo Classifications — 1 product code
- Part 864 Subpart E—Specimen Preparation Reagents — 61 product codes
- Part 866 Subpart D—Serological Reagents — 2 product codes
- Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems — 4 product codes
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| PRB | Cervical Intraepithelial Neoplasia (Cin) Test System | 864.1865 | 2 | 2 |
| IDL | Microtome, Accessories | 864.3010 | 1 | 5 |
| IDM | Microtome, Ultra | 864.3010 | 1 | 1 |
| IDN | Microtome, Freezing Attachment | 864.3010 | 1 | 0 |
| IDO | Microtome, Rotary | 864.3010 | 1 | 5 |
| IDP | Microtome, Cryostat | 864.3010 | 1 | 1 |
| IDQ | Infiltrator | 864.3010 | 1 | 0 |
| IDR | Ovens, Paraffin | 864.3010 | 1 | 0 |
| IDS | Melting Pot, Paraffin | 864.3010 | 1 | 1 |
| IDT | Apparatus, Melting Point, Paraffin | 864.3010 | 1 | 0 |
| IDW | Dispensers, Paraffin | 864.3010 | 1 | 1 |
| IDX | Sieves, Tissue | 864.3010 | 1 | 0 |
| IDY | Bath, Flotation, Tissue | 864.3010 | 1 | 0 |
| IDZ | Cassettes, Tissue | 864.3010 | 1 | 5 |
| IEG | Table, Slide Warming | 864.3010 | 1 | 1 |
| IEH | Lamps, Slide Warming | 864.3010 | 1 | 0 |
| IHJ | Blender, Sputum | 864.3010 | 1 | 0 |
| KDZ | Device, Decalcifier, Electrolytic | 864.3010 | 1 | 0 |
| KER | Container, Embedding | 864.3010 | 1 | 5 |
| KES | Coverslips, Microscope Slide | 864.3010 | 1 | 3 |
| KET | Filters, Cell Collection, Tissue Processing | 864.3010 | 1 | 5 |
| KEW | Slides, Microscope | 864.3010 | 1 | 8 |
| KFL | Microtome, Sliding | 864.3010 | 1 | 0 |
| KJG | Tube, Tissue Culture | 864.3010 | 1 | 1 |
| LEC | Grinder, Tissue | 864.3010 | 1 | 0 |
| MJI | Specimen/Tissue, Identification Orientation | 864.3010 | 1 | 0 |
| MXT | Device, Accessory, Cooling Plate For Tissue Embedding Station | 864.3010 | 1 | 0 |
| FMH | Container, Specimen, Sterile | 864.3250 | 1 | 23 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 864.3250 | 1 | 12 |
| KDW | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | 864.3250 | 1 | 4 |
| NNI | Container, Specimen, Non-Sterile | 864.3250 | 1 | 0 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | 864.3250 | 1 | 0 |
| NNL | Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | 864.3250 | 1 | 0 |
| OHZ | Urine Transport Kit (Excludes Hiv Testing) | 864.3250 | 1 | 0 |
| OIA | Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) | 864.3250 | 1 | 0 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 864.3250 | 1 | 0 |
| OIE | Urine Collection Kit (Excludes Hiv Testing) | 864.3250 | 1 | 0 |
| MPQ | Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | 864.3260 | 1 | 0 |
| IFB | Cytocentrifuge | 864.3300 | 1 | 3 |
| KIM | Device For Sealing Microsections | 864.3400 | 1 | 1 |
| IBJ | Light, Microscope | 864.3600 | 1 | 9 |
| IBK | Microscope, Fluorescence/U.V. | 864.3600 | 1 | 1 |
| IBL | Microscope, Inverted Stage, Tissue Culture | 864.3600 | 1 | 0 |
| IBM | Microscope, Phase Contrast | 864.3600 | 1 | 1 |
| KEG | Lamps, Microscope | 864.3600 | 1 | 0 |
| KEH | Micrometers, Microscope | 864.3600 | 1 | 0 |
| KEI | Condensers, Microscope | 864.3600 | 1 | 0 |
| KEJ | Stages, Microscope | 864.3600 | 1 | 1 |
| PSY | Whole Slide Imaging System | 864.3700 | 2 | 19 |
| PZZ | Digital Pathology Display | 864.3700 | 2 | 3 |
| QKQ | Digital Pathology Image Viewing And Management Software | 864.3700 | 2 | 13 |
| QPN | Software Algorithm Device To Assist Users In Digital Pathology | 864.3750 | 2 | 2 |
| SFH | Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis | 864.3755 | 2 | 1 |
| KEY | Stainer, Tissue, Automated | 864.3800 | 1 | 1 |
| KIN | Slide Stainer, Contact Type | 864.3800 | 1 | 1 |
| KIO | Slide Stainer, Immersion Type | 864.3800 | 1 | 1 |
| KPA | Slide Stainer, Automated | 864.3800 | 1 | 21 |
| IEO | Processor, Tissue, Automated | 864.3875 | 1 | 12 |
| QYV | Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm | 864.3900 | 2 | 1 |
| HZI | Acid, Osmic | 864.4010 | 1 | 0 |
| IAL | Iodine (Tincture) | 864.4010 | 1 | 0 |
| IAM | Solution, Lugol'S | 864.4010 | 1 | 0 |
| IAT | Syrup, Gum, Apathy'S | 864.4010 | 1 | 0 |
| IAW | Collodion | 864.4010 | 1 | 0 |
| IAY | Colchicine | 864.4010 | 1 | 0 |
| IBB | Phytohemaglutinin M | 864.4010 | 1 | 0 |
| IER | Polyethylene Glycol (Carbowax) | 864.4010 | 1 | 1 |
| IEX | Gelatin | 864.4010 | 1 | 0 |
| IEZ | Celloidin | 864.4010 | 1 | 0 |
| IFF | Solution, Decalcifier, Electrolytic | 864.4010 | 1 | 0 |
| IFH | Solution, Zenker'S | 864.4010 | 1 | 2 |
| IFI | Sprays, Synthetic, Smear | 864.4010 | 1 | 1 |
| IFJ | Fixative, Richardson Glycol | 864.4010 | 1 | 0 |
| IFL | Polyethylene Glycol Preservative | 864.4010 | 1 | 0 |
| IFN | Solution, Orth'S | 864.4010 | 1 | 0 |
| IFO | Solution, Newcomer'S | 864.4010 | 1 | 0 |
| IFP | Formalin, Neutral Buffered | 864.4010 | 1 | 15 |
| IFQ | Formulations, Mercuric Chloride For Tissue | 864.4010 | 1 | 2 |
| IFS | Solution, Helly | 864.4010 | 1 | 0 |
| IFT | Glutaraldehyde | 864.4010 | 1 | 1 |
| IFY | Gelatin-Formalin | 864.4010 | 1 | 0 |
| IFZ | Gelatin For Specimen Adhesion | 864.4010 | 1 | 1 |
| IGB | Solution, Formalin-Sodium Acetate | 864.4010 | 1 | 1 |
| IGC | Formalin-Saline | 864.4010 | 1 | 2 |
| IGD | Solution, Formol Calcium | 864.4010 | 1 | 0 |
| IGE | Solution, Formalin Ammonium Bromide | 864.4010 | 1 | 2 |
| IGF | Solution, Formalin-Alcohol-Acetic Acid | 864.4010 | 1 | 1 |
| IGG | Formaldehyde (Formalin, Formol) | 864.4010 | 1 | 7 |
| IGK | Solution, Clarke'S | 864.4010 | 1 | 0 |
| IGM | Solution, Carnoy'S | 864.4010 | 1 | 3 |
| IGN | Fluid, Bouin'S | 864.4010 | 1 | 2 |
| IJZ | Oil, Clearing | 864.4010 | 1 | 1 |
| JCB | Detergent | 864.4010 | 1 | 0 |
| JCC | Ph Buffer | 864.4010 | 1 | 7 |
| JCE | Solution, Isotonic | 864.4010 | 1 | 7 |
| KDX | Solution, Decalcifier, Acid Containing | 864.4010 | 1 | 8 |
| KDY | Agent, Chelating For Decalcification | 864.4010 | 1 | 0 |
| KEE | Osmium Tetroxide | 864.4010 | 1 | 0 |
| KEF | Paraformaldehyde | 864.4010 | 1 | 0 |
| KEL | Adhesive, Albumin-Based | 864.4010 | 1 | 2 |
| KEM | Agent, Clearing | 864.4010 | 1 | 15 |
| KEO | Formulations, Paraffin, All | 864.4010 | 1 | 11 |
| KEP | Media, Mounting, Oil Soluble | 864.4010 | 1 | 3 |
| KEQ | Media, Mounting, Water Soluble | 864.4010 | 1 | 7 |
| LDW | Fixative, Acid Containing | 864.4010 | 1 | 4 |
| LDX | Fixative, Metallic Containing | 864.4010 | 1 | 1 |
| LDY | Fixative, Formalin-Containing | 864.4010 | 1 | 1 |
| LDZ | Fixative, Alcohol Containing | 864.4010 | 1 | 8 |
| LEA | Preservative, Cytological | 864.4010 | 1 | 4 |
| LEB | Mounting Media | 864.4010 | 1 | 5 |
| PPM | General Purpose Reagent | 864.4010 | 1 | 16 |
| MVU | Reagents, Specific, Analyte | 864.4020 | 1 | 0 |
| IAZ | Heparin | 864.4400 | 1 | 0 |
| IBA | Streptolysin O | 864.4400 | 1 | 0 |
| IBC | Diastase | 864.4400 | 1 | 0 |
| IBD | Hyaluronidase | 864.4400 | 1 | 0 |
| IBE | Neuramininase (Sialidase) | 864.4400 | 1 | 0 |
| IBF | Papain | 864.4400 | 1 | 0 |
| IBG | Trypsin | 864.4400 | 1 | 2 |
| LIJ | Peroxidase Anti-Peroxidase Immunohistochemical Stain | 864.4400 | 1 | 2 |
| PZF | Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System | 866.4001 | 2 | 1 |
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System | 866.4001 | 2 | 3 |
| PZM | Next Generation Sequencing Based Tumor Profiling Test | 866.6080 | 2 | 7 |
| SBY | High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | 866.6085 | 2 | 1 |
| QVU | High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System. | 866.6095 | 2 | 1 |
| QDC | Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies | 866.6100 | 2 | 2 |
