← Product Code [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS) · K884100

# AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 (K884100)

_Amersham Corp. · JLS · Nov 10, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K884100

## Device Facts

- **Applicant:** Amersham Corp.
- **Product Code:** [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS.md)
- **Decision Date:** Nov 10, 1988
- **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/K884100](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K884100)

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