I-STAT IONIZED CALCIUM TEST
Device Facts
| Record ID | K934642 |
|---|---|
| Device Name | I-STAT IONIZED CALCIUM TEST |
| Applicant | I-Stat Corp. |
| Product Code | JFP · Clinical Chemistry |
| Decision Date | Dec 17, 1993 |
| 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).
