GKX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrument, Automated Platelet Counting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- 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 |
|---|---|---|
| ABX MICROS 60 HEMATOLOGY ANALYZER (K014203) | Abx Diagnostics | 2002-02-28 |
| CLEAR POROUS PLASTIC-HYPOALLERGENIC (K840948) | Gainor Medical | 1984-08-14 |
Track GKX automatically
Every clearance here is in the API, with alerts when new ones post.