QUANTIMETRIX C-CLEAR(TM)
Device Facts
| Record ID | K931523 |
|---|---|
| Device Name | QUANTIMETRIX C-CLEAR(TM) |
| Applicant | Quantimetrix Corp. |
| Product Code | JMA · Clinical Chemistry |
| Decision Date | Jun 25, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1095 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.