KFC
7 FDA 510(k) clearances · Product code
48 daysmedian time to decision
71 days90th percentile
7clearances measured
FDA profile
- Official device name
- Methylene Blue, Tissue Stain
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1999: 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 |
|---|---|---|
| RETICULOCYTE STAIN (K875310) | Sigma Diagnostics, Inc. | 1988-02-09 |
| SPOTTEST LOEFFLER METHYLENE BLUE STAIN (K843919) | Difco Laboratories, Inc. | 1984-10-30 |
| METHYLENE BLUE STAIN, LOEFFLER (K842926) | E K Ind., Inc. | 1984-09-11 |
| STAIN, METHYLENE BLUE-EOSIN (K842785) | Reagent Laboratory, Inc. | 1984-09-11 |
| NEW METHYLENE BLUE N (K842743) | E K Ind., Inc. | 1984-08-12 |
| NEPHROLYTE (K831502) | Flaitron Laboratories, Inc. | 1983-07-18 |
| TUBE, STAIN, RETICULOCYTE, LARC (K770792) | Corning Medical & Scientific | 1977-07-05 |
Track KFC automatically
Every clearance here is in the API, with alerts when new ones post.