← Product Code [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS) · K854675

# DSL ANDROSTENEDIONE RIA (DSL #4200) (K854675)

_Diagnostic Systems Laboratories, Inc. · JLS · Jan 28, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K854675

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS.md)
- **Decision Date:** Jan 28, 1986
- **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/K854675](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K854675)

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