COBAS REAGENT FOR CALCIUM
Device Facts
| Record ID | K823577 |
|---|---|
| Device Name | COBAS REAGENT FOR CALCIUM |
| Applicant | Hoffmann-La Roche, Inc. |
| Product Code | CIC · Clinical Chemistry |
| Decision Date | Jan 7, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1145 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
