FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALK-PHOS BIOPAK GEL
K Number: K810144
·
Decision Feb 2, 1981
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
25
Applicant Total
4
Review Days
12
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Basic Information
- Device Name
- ALK-PHOS BIOPAK GEL
- K Number
- K810144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bioware Products
- Date Received
- January 21, 1981
- Decision Date
- February 2, 1981
- Product Code
- CIN
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | FDA class 2 | Clinical Chemistry |
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