ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
Device Facts
| Record ID | K003093 |
|---|---|
| Device Name | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 |
| Applicant | Diagnostic Chemicals , Ltd. |
| Product Code | CJE · Clinical Chemistry |
| Decision Date | Nov 27, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
Regulatory Classification
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.
