HYB
10 FDA 510(k) clearances · Product code
23 daysmedian time to decision
49 days90th percentile
10clearances measured
FDA profile
- Official device name
- Eosin Y
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| INSTANT EOSIN-AQUEOUS (K893663) | Shandon, Inc. | 1989-06-13 |
| EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (K880596) | Sigma Chemical Co. | 1988-03-31 |
| INSTANT EOSIN-ALCOHOLIC (K880240) | Shandon, Inc. | 1988-03-03 |
| EOSIN Y 1% ALCOHOLIC (K843426) | Accra Laboratories, Inc. | 1984-09-27 |
| MIDAS 100 HEMACOLOR STAIN #66030 (K822982) | Emd Chemicals, Inc. | 1982-10-27 |
| EOSIN Y SOLUTIN, AGUEOUS (K821574) | Sigma Chemical Co. | 1982-06-10 |
| EOSIN Y SOLUTION ALCHOLIC (K821573) | Sigma Chemical Co. | 1982-06-09 |
| EOSIN-Y (K811797) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| EOSIN Y (K811826) | Surgipath | 1981-07-10 |
| VOLU-SOL EOSIN Y STAIN (K800942) | Volu Sol Medical Industries | 1980-05-08 |
Track HYB automatically
Every clearance here is in the API, with alerts when new ones post.