FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALKPHOR SYSTEM
K Number: K823445
·
Decision Dec 28, 1982
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
25
Applicant Total
3
Review Days
42
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Basic Information
- Device Name
- ALKPHOR SYSTEM
- K Number
- K823445
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- California Immuno Diagnostic, Inc.
- Date Received
- November 16, 1982
- Decision Date
- December 28, 1982
- 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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