FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HARRIS HEMATOXYLIN
K Number: K810733
·
Decision Apr 14, 1981
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
6
Applicant Total
12
Review Days
27
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HARRIS HEMATOXYLIN
- K Number
- K810733
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Surgipath
- Date Received
- March 18, 1981
- Decision Date
- April 14, 1981
- Product Code
- HYK
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HYK | Hematoxylin Harris'S | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HYK), ordered by most recent decision date.
INSTANT HEMATOXYLIN
FDA 510(k)
FDA Class 1
·Hematology
HARRIS HEMATOXYLIN
FDA 510(k)
FDA Class 1
·Hematology
HARRIS HEMATOXYLIN, MERCURY FREE, ACID
FDA 510(k)
FDA Class 1
·Hematology
HARRIS HEMATOXYLIN
FDA 510(k)
FDA Class 1
·Hematology
VOLU-SOL HARRIS HEMATOXYLIN
FDA 510(k)
FDA Class 1
·Hematology
HEMATOXYLIN STAIN HARRIS
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Surgipath
| K Number | Device Name | ||
|---|---|---|---|
| K820027 | MODIFIED EA 50 | Feb 4, 1982 | Substantially Equivalent |
| K812940 | 10% NEUTRAL BUFFERED FORMALIN CONCENT | Dec 10, 1981 | Substantially Equivalent |
| K812087 | EA 50 | Aug 13, 1981 | Substantially Equivalent |
| K812086 | EA 65 | Aug 13, 1981 | Substantially Equivalent |
| K811825 | ORANGE G-6 | Jul 10, 1981 | Substantially Equivalent |
| K811826 | EOSIN Y | Jul 10, 1981 | Substantially Equivalent |
| K810836 | DECALCIFIER II | Apr 23, 1981 | Substantially Equivalent |
| K810758 | GILL'S HEMATOXYLIN #1 | Apr 14, 1981 | Substantially Equivalent |
| K810759 | GILL'S HEMATOXYLIN #2 | Apr 14, 1981 | Substantially Equivalent |
| K810760 | GILL'S HEMATOXYLIN #3 | Apr 14, 1981 | Substantially Equivalent |