CJL · Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1050 · Class 2
Overview
| Product Code | CJL |
|---|---|
| Device Name | Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Classification Rationale
Class II.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K812837 | ALKALINE PHOSPHATASE REAGENT SET | Anco Medical Reagents & Assoc. | Jan 29, 1982 | SESE |
Top Applicants
- Anco Medical Reagents & Assoc. — 1 clearance
