← Product Code [CFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT) · K843804

# TANDEM - EPRL (K843804)

_Hybritech, Inc. · CFT · Nov 13, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K843804

## Device Facts

- **Applicant:** Hybritech, Inc.
- **Product Code:** [CFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT.md)
- **Decision Date:** Nov 13, 1984
- **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/K843804](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K843804)

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