KEY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Stainer, Tissue, Automated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3800
- Medical specialty
- Pathology
- Adverse events (MAUDE)
- 2008: 3 · 2010: 4
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 |
|---|---|---|
| SLIDE STAINERS GLS 360 & 360-1 (K771714) | Honeywell, Inc. | 1977-10-05 |
Track KEY automatically
Every clearance here is in the API, with alerts when new ones post.