HYK
7 FDA 510(k) clearances · Product code
22 daysmedian time to decision
50 days90th percentile
7clearances measured
FDA profile
- Official device name
- Hematoxylin Harris'S
- 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 HEMATOXYLIN (K873107) | Shandon, Inc. | 1987-08-21 |
| HARRIS HEMATOXYLIN (K872498) | Anatech, Ltd. | 1987-07-09 |
| HARRIS HEMATOXYLIN, MERCURY FREE, ACID (K843425) | Accra Laboratories, Inc. | 1984-10-02 |
| HARRIS HEMATOXYLIN (K823328) | Accra Laboratories, Inc. | 1982-12-28 |
| HARRIS HEMATOXYLIN (K810733) | Surgipath | 1981-04-14 |
| VOLU-SOL HARRIS HEMATOXYLIN (K800324) | Volu Sol Medical Industries | 1980-02-22 |
| HEMATOXYLIN STAIN HARRIS (K781585) | Bioscientific | 1978-10-10 |
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Every clearance here is in the API, with alerts when new ones post.