HYJ
14 FDA 510(k) clearances · Product code
25 daysmedian time to decision
35 days90th percentile
14clearances measured
FDA profile
- Official device name
- Hematoxylin
- 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 |
|---|---|---|
| ANATECH HEMATOXYLIN-NORMAL STRENGTH (K872499) | Anatech, Ltd. | 1987-07-09 |
| ANATECH HEMATOXYLIN-EXTRA STRENGTH (K872500) | Anatech, Ltd. | 1987-07-09 |
| DELAFIELD HEMATOXYLIN STAIN (K842740) | E K Ind., Inc. | 1984-08-17 |
| GILL HEMATOXYLIN STAIN (K842741) | E K Ind., Inc. | 1984-08-15 |
| HEMATOXYLIN GILL FORMULATION IX#56016 (K831090) | Accra Laboratories, Inc. | 1983-06-08 |
| HEMATOXYLIN STAIN SOLUTION (K822352) | Fisher Scientific Co., LLC | 1982-08-16 |
| HEMATOXYLIN I (K821533) | Volu Sol Medical Industries | 1982-06-10 |
| HEMATOXYLIN II (K821540) | Volu Sol Medical Industries | 1982-06-10 |
| HEMATOXYLIN III (K821541) | Volu Sol Medical Industries | 1982-06-10 |
| HEMATOXYLIN STAIN (K821320) | Sigma Chemical Co. | 1982-06-02 |
| HEMATOXYLIN SOLUTION (K821062) | Sigma Chemical Co. | 1982-04-29 |
| HEMATOXYLIN (K811802) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| GILL'S HEMATOXYLIN #1 (K810758) | Surgipath | 1981-04-14 |
| GILL'S HEMATOXYLIN #2 (K810759) | Surgipath | 1981-04-14 |
Track HYJ automatically
Every clearance here is in the API, with alerts when new ones post.