← Product Code [JMA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMA) · K830978

# HELENA BIOSTRIP A (K830978)

_Helena Laboratories · JMA · May 13, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMA/K830978

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JMA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMA.md)
- **Decision Date:** May 13, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1095
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMA/K830978](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMA/K830978)

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