Part 864 Subpart G—Manual Hematology Devices
FDA submissions for Part 864 Subpart G—Manual Hematology Devices in the Hematology (HE) review panel, including product codes and regulations.
Section range: §§ 864.6100–864.6700
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| JCA | Device, Bleeding Time | 864.6100 | 2 | 7 |
| GIO | Tube, Collection, Capillary Blood | 864.6150 | 1 | 22 |
| GGX | Pipette, Sahli | 864.6160 | 1 | 2 |
| GGY | Pipette, Diluting | 864.6160 | 1 | 0 |
| GHO | Hemocytometer | 864.6160 | 1 | 2 |
| GJG | Pipette, Quantitative, Hematology | 864.6160 | 1 | 4 |
| GJW | Pipette, Pasteur | 864.6160 | 1 | 4 |
| GKM | Hand-Tally, Differential | 864.6160 | 1 | 4 |
| GLG | Platelet Counting, Manual | 864.6160 | 1 | 3 |
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | 864.6400 | 2 | 2 |
| GKG | Centrifuge, Hematocrit | 864.6400 | 2 | 11 |
| JPI | Device, Hematocrit Measuring | 864.6400 | 2 | 15 |
| GGG | Guaiac Reagent | 864.6550 | 2 | 1 |
| JIO | Blood, Occult, Colorimetric, In Urine | 864.6550 | 2 | 11 |
| JIP | Blood, Occult, Enzymatic Method, In Urine | 864.6550 | 2 | 0 |
| KHE | Reagent, Occult Blood | 864.6550 | 2 | 97 |
| NGK | Test, Occult Blood, Over The Counter | 864.6550 | 2 | 0 |
| OOX | Automated Occult Blood Analyzer | 864.6550 | 2 | 6 |
| OSL | Control, Fecal Occult Blood | 864.6550 | 2 | 1 |
| GKE | Osmotic Fragility Testing | 864.6600 | 1 | 0 |
| JBZ | Study, Platelet Adhesive | 864.6650 | 2 | 3 |
| GKW | Aggregometer, Platelet, Thrombokinetogram | 864.6675 | 2 | 0 |
| JBX | Aggregrometer, Platelet | 864.6675 | 2 | 12 |
| JBY | Aggregometer, Platelet, Photo-Optical Scanning | 864.6675 | 2 | 2 |
| GHC | Tube, Sedimentation Rate | 864.6700 | 1 | 1 |
| JPH | Test, Erythrocyte Sedimentation Rate | 864.6700 | 1 | 7 |
