← Product Code [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN) · K893684

# CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY (K893684)

_Ciba Corning Diagnostics Corp. · CGN · Jul 27, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K893684

## Device Facts

- **Applicant:** Ciba Corning Diagnostics Corp.
- **Product Code:** [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN.md)
- **Decision Date:** Jul 27, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1295
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K893684](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K893684)

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