KSF
12 FDA 510(k) clearances · Product code
36 daysmedian time to decision
97 days90th percentile
12clearances measured
FDA profile
- Official device name
- Kit, Quality Control For Blood Banking Reagents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9650
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2000: 2 · 2007: 2 · 2011: 18 · 2016: 16 · 2017: 19 · 2018: 20
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 |
|---|---|---|
| AVI-D CONTROL (K811713) | Ortho Diagnostic Systems, Inc. | 1981-10-23 |
| DADE RH CONTROL REAGENT (K810599) | American Dade | 1981-03-31 |
| RH CONTROL (K801425) | North American Biologicals, Inc. | 1980-07-14 |
| RST-SERIES CONTROL (K800658) | Gamma Biologicals, Inc. | 1980-04-16 |
| ORTHO ANTISERA CONTROL (K800310) | Ortho Diagnostics, Inc. | 1980-03-05 |
| RH-HR NEGATIVE CONTROL REAGENT (K800239) | Gotham Biologics, Inc. | 1980-02-21 |
| TEST CELLS (K790249) | Hyland Therapeutic Div., Travenol Laboratories | 1979-05-16 |
| COUNTER CHECK, H001, H002, H003 (K790025) | Diagnostic Technology, Inc. | 1979-01-17 |
| RECAP (K780665) | Bca Biological Corp. of America | 1978-06-06 |
| QUALITY CONTROL SYSTEM, SPECTRA (K780097) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
| REAGENT CONFIDENCE SERA (K771814) | Ortho Diagnostics, Inc. | 1977-11-07 |
| UNIVAL CONTROL CELLS (K761284) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-01-25 |
Track KSF automatically
Every clearance here is in the API, with alerts when new ones post.