HARRIS HEMATOXYLIN
FDA 510(k) clearance K823328 · decided 1982-12-28
Clearance details
- K-number
- K823328
- Device name
- HARRIS HEMATOXYLIN
- Applicant
- Accra Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-08
- Decision date
- 1982-12-28
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HYK
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 (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 |
Recalls involving this device
No recalls on record reference this clearance.