JBY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Aggregometer, Platelet, Photo-Optical Scanning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6675
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PACKS-4 (TM) ANALYZER (K912201) | Helena Laboratories | 1991-08-16 |
| LUMI-AGGREGOMETER (K771198) | Chrono-Log Corp. | 1977-08-02 |
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