ICF
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
95 days90th percentile
5clearances measured
FDA profile
- Official device name
- Crystal Violet For Histology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 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 |
|---|---|---|
| TISSUE GRAM STAIN (K864531) | Sigma Diagnostics, Inc. | 1986-12-22 |
| VON WILLEBRAND FACTOR ANTIGEN SCREEN (K842537) | American Dade | 1984-10-01 |
| GENTIAN VIOLET (K842730) | E K Ind., Inc. | 1984-08-03 |
| IRIS URINE STAIN (K821503) | Intl. Remote Imaging Systems | 1982-06-03 |
| VOLU-SOL URINARY SEDIMENT STAIN (K792495) | Volu Sol Medical Industries | 1979-12-18 |
Track ICF automatically
Every clearance here is in the API, with alerts when new ones post.