Part 864 Subpart D—Pathology Instrumentation and Accessories
FDA submissions for Part 864 Subpart D—Pathology Instrumentation and Accessories in the Pathology (PA) review panel, including product codes and regulations.
Section range: §§ 864.3010–864.3875
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| 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 |
