KQC
9 FDA 510(k) clearances · Product code
37 daysmedian time to decision
64 days90th percentile
9clearances measured
FDA profile
- Official device name
- Stains, Hematology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2011: 5
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 |
|---|---|---|
| FIELDTEX HEMATOXYLIN (K882873) | Anatech, Ltd. | 1988-07-28 |
| GENERAL DIAGNOSTICS COAG-A-MATE XC (K852843) | Warner-Lambert Co. | 1985-08-13 |
| RETIC-SET (K843619) | R&D Systems, Inc. | 1984-10-30 |
| RETIC-SET (K841848) | R&D Systems, Inc. | 1984-05-31 |
| PONCEAU S STAIN SET (K792550) | Electrophoresis Corp. of America | 1980-01-16 |
| VOLU-SOL NMB RETICULOCYTE STAIN (K792496) | Volu Sol Medical Industries | 1979-12-31 |
| STAT DIFF STAIN (K791007) | Bioscientific | 1979-08-03 |
| HEMASTAIN FIXATIVE (K760485) | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
| HEMASTAIN PHOSPHATE BUFFER (K760487) | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
Track KQC automatically
Every clearance here is in the API, with alerts when new ones post.