LOQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, General Purpose, Hematology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 2 · 1995: 2 · 1996: 1 · 2010: 25 · 2011: 56
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 |
|---|---|---|
| ACS:CENTAUR AFP (K981592) | Chiron Diagnostics Corp. | 1998-07-07 |
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Every clearance here is in the API, with alerts when new ones post.