← Product Code [CFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT) · K894988

# CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY (K894988)

_Ciba Corning Diagnostics Corp. · CFT · Oct 12, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K894988

## Device Facts

- **Applicant:** Ciba Corning Diagnostics Corp.
- **Product Code:** [CFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT.md)
- **Decision Date:** Oct 12, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1625
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K894988](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K894988)

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