FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTANT HEMATOXYLIN
K Number: K873107
·
Decision Aug 21, 1987
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
6
Applicant Total
5
Review Days
14
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Basic Information
- Device Name
- INSTANT HEMATOXYLIN
- K Number
- K873107
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Shandon, Inc.
- Date Received
- August 7, 1987
- Decision Date
- August 21, 1987
- 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 |
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