FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALKALINE PHOSPHATASE
K Number: K964914
·
Decision Feb 4, 1997
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
18
Review Days
57
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Basic Information
- Device Name
- ALKALINE PHOSPHATASE
- K Number
- K964914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Derma Media Lab., Inc.
- Date Received
- December 9, 1996
- Decision Date
- February 4, 1997
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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Other Clearances by Derma Media Lab., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971309 | UREA | Aug 1, 1997 | Substantially Equivalent |
| K970664 | GLUCOSE REAGENT | Aug 1, 1997 | Substantially Equivalent |
| K971072 | CHOLESTEROL REAGENT | Jun 20, 1997 | Substantially Equivalent |
| K971005 | TRIGLYCERIDES | Apr 21, 1997 | Substantially Equivalent |
| K970867 | URIC ACID REAGENT | Apr 21, 1997 | Substantially Equivalent |
| K964915 | MAGNESIUM | Mar 26, 1997 | Substantially Equivalent |
| K964913 | IRON REAGENT | Feb 20, 1997 | Substantially Equivalent |
| K965134 | ALT/SGPT | Feb 18, 1997 | Substantially Equivalent |
| K965126 | AST/SGOT | Jan 17, 1997 | Substantially Equivalent |
| K964916 | GAMMA-GLUTAMYL TRANSPEPTIDASE | Jan 10, 1997 | Substantially Equivalent |