N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
Device Facts
| Record ID | K003609 |
|---|---|
| Device Name | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 |
| Applicant | Osteometer Biotech A/S |
| Product Code | NEO · Clinical Chemistry |
| Decision Date | May 16, 2001 |
| 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.
