QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL)
Device Facts
| Record ID | K871903 |
|---|---|
| Device Name | QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) |
| Applicant | Creative Scientific Technology, Inc. |
| Product Code | JFN · Clinical Chemistry |
| Decision Date | Sep 2, 1987 |
| 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).
