FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GILL'S HEMATOXYLIN #2
K Number: K810759
·
Decision Apr 14, 1981
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
13
Applicant Total
12
Review Days
25
Basic Information
- Device Name
- GILL'S HEMATOXYLIN #2
- K Number
- K810759
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- SURGIPATH
- Date Received
- March 20, 1981
- Decision Date
- April 14, 1981
- Product Code
- HYJ
- 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 |
|---|---|---|---|
| HYJ | Hematoxylin | FDA class 1 | Hematology |
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HEMATOXYLIN STAIN SOLUTION
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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 |
| K812086 | EA 65 | Aug 13, 1981 | Substantially Equivalent |
| K812087 | EA 50 | 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 |
| K810733 | HARRIS HEMATOXYLIN | Apr 14, 1981 | Substantially Equivalent |
| K810758 | GILL'S HEMATOXYLIN #1 | Apr 14, 1981 | Substantially Equivalent |
| K810760 | GILL'S HEMATOXYLIN #3 | Apr 14, 1981 | Substantially Equivalent |