URITEST 9, INLAB REAGENT STRIPS URINALY
Device Facts
| Record ID | K822709 |
|---|---|
| Device Name | URITEST 9, INLAB REAGENT STRIPS URINALY |
| Applicant | Laprol Scientific, Inc. |
| Product Code | JMA · Clinical Chemistry |
| Decision Date | Jan 28, 1983 |
| 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.
