GGO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reagent, Thromboplastin And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2001: 1 · 2003: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (K010158) | Sigma Diagnostics, Inc. | 2001-03-22 |
Track GGO automatically
Every clearance here is in the API, with alerts when new ones post.