ROCHE REAGENT FOR CALCIUM
Device Facts
| Record ID | K883453 |
|---|---|
| Device Name | ROCHE REAGENT FOR CALCIUM |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | CJY · Clinical Chemistry |
| Decision Date | Oct 25, 1988 |
| 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).
