GKB
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, Automated Sedimentation Rate
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.5800
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2001: 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 |
|---|---|---|
| SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED (K892522) | Gespac, Inc. | 1989-05-24 |
| SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE (K890503) | Gespac, Inc. | 1989-02-10 |
Track GKB automatically
Every clearance here is in the API, with alerts when new ones post.