ATAC PAK ALP REAGENT KIT
Device Facts
| Record ID | K002285 |
|---|---|
| Device Name | ATAC PAK ALP REAGENT KIT |
| Applicant | Elan Diagnostics |
| Product Code | CJE · Clinical Chemistry |
| Decision Date | Sep 26, 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.
