← Product Code [CFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT) · K820039

# LEECO PRL-QUANT DIAGNOSTIC TEST KIT (K820039)

_Leeco Diagnostics, Inc. · CFT · Jan 22, 1982 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K820039

## Device Facts

- **Applicant:** Leeco Diagnostics, Inc.
- **Product Code:** [CFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT.md)
- **Decision Date:** Jan 22, 1982
- **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/K820039](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K820039)

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