HEMATOXYLIN I
FDA 510(k) clearance K821533 · decided 1982-06-10
Clearance details
- K-number
- K821533
- Device name
- HEMATOXYLIN I
- Applicant
- Volu Sol Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1982-05-21
- Decision date
- 1982-06-10
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- HYJ
- 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 |
|---|---|---|
| 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 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 |
Recalls involving this device
No recalls on record reference this clearance.