HELENA BIOSTRIP A
Device Facts
| Record ID | K830978 |
|---|---|
| Device Name | HELENA BIOSTRIP A |
| Applicant | Helena Laboratories |
| Product Code | JMA · Clinical Chemistry |
| Decision Date | May 13, 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.
