← Product Code [CFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT) · K944698

# AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698)

_Organon Teknika Corp. · CFT · Mar 21, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K944698

## Device Facts

- **Applicant:** Organon Teknika Corp.
- **Product Code:** [CFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT.md)
- **Decision Date:** Mar 21, 1995
- **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/K944698](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFT/K944698)

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