FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANATECH HEMATOXYLIN-EXTRA STRENGTH
K Number: K872500
·
Decision Jul 9, 1987
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
13
Applicant Total
14
Review Days
15
Basic Information
- Device Name
- ANATECH HEMATOXYLIN-EXTRA STRENGTH
- K Number
- K872500
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- ANATECH, LTD.
- Date Received
- June 24, 1987
- Decision Date
- July 9, 1987
- 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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Other Clearances by ANATECH, LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K882874 | ZINC FORMALIN | Jul 28, 1988 | Substantially Equivalent |
| K882873 | FIELDTEX HEMATOXYLIN | Jul 28, 1988 | Substantially Equivalent |
| K882268 | ZINC FORMALIN CONCENTRATE | Jun 15, 1988 | Substantially Equivalent |
| K881282 | XYLENE | Apr 5, 1988 | Substantially Equivalent |
| K872663 | DRY-FORM | Aug 6, 1987 | Substantially Equivalent |
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | Jul 9, 1987 | Substantially Equivalent |
| K872498 | HARRIS HEMATOXYLIN | Jul 9, 1987 | Substantially Equivalent |
| K870852 | NBF 10% NEUTRAL BUFFERED FORMALIN | Mar 31, 1987 | Substantially Equivalent |
| K842940 | CBA FORMALIN | Aug 28, 1984 | Substantially Equivalent |
| K842862 | CB FORMALIN | Aug 28, 1984 | Substantially Equivalent |