KSN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Centrifuge, Cell-Washing, Automated For Immuno-Hematology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9285
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1992: 1 · 1994: 1
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 |
|---|---|---|
| IMMU-TEK AUTOMATIC CENTRIFUGE (K790767) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 |
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Every clearance here is in the API, with alerts when new ones post.