← Product Code [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS) · K832694

# DIRIA-PROGK IMMUNOASSAY (K832694)

_Sorin Biomedica, Fiat, USA, Inc. · JLS · Jan 11, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K832694

## Device Facts

- **Applicant:** Sorin Biomedica, Fiat, USA, Inc.
- **Product Code:** [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS.md)
- **Decision Date:** Jan 11, 1984
- **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/K832694](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K832694)

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