FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PVA FIXATIVE/FORMALIN
K Number: K831061
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
7
Applicant Total
24
Review Days
68
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Basic Information
- Device Name
- PVA FIXATIVE/FORMALIN
- K Number
- K831061
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- American Micro Scan
- Date Received
- April 1, 1983
- Decision Date
- June 8, 1983
- Product Code
- LDZ
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| LDZ | Fixative, Alcohol Containing | FDA class 1 | Pathology |
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