SANDARE FAST 340 PHOSPHORUS PROCEDURE
Device Facts
| Record ID | K812670 |
|---|---|
| Device Name | SANDARE FAST 340 PHOSPHORUS PROCEDURE |
| Applicant | Sandare Chemical Co., Inc. |
| Product Code | CED · Clinical Chemistry |
| Decision Date | Oct 2, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1520 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A 5′-nucleotidase test system is a device intended to measure the activity of the enzyme 5′-nucleotidase in serum and plasma. Measurements of 5′-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity.
