FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ISOTONIC DILUENT AF
K Number: K761182
·
Decision Dec 9, 1976
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
3
Review Days
7
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Basic Information
- Device Name
- ISOTONIC DILUENT AF
- K Number
- K761182
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Central Labs. Assoc. MD Pathologists
- Date Received
- December 2, 1976
- Decision Date
- December 9, 1976
- Product Code
- GGK
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | FDA class 1 | Hematology |
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