STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
Device Facts
| Record ID | K960120 |
|---|---|
| Device Name | STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS |
| Applicant | Nova Biomedical Corp. |
| Product Code | JFP · Clinical Chemistry |
| Decision Date | Mar 11, 1996 |
| 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).
