← Product Code [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS) · K910683

# ENZYMUN-TEST PROGESTERONE (K910683)

_Boehringer Mannheim Corp. · JLS · Apr 8, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K910683

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS.md)
- **Decision Date:** Apr 8, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1620
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K910683](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K910683)

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