← Product Code [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS) · K920230

# AFFINITY PRG (K920230)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · JLS · Feb 18, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K920230

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [JLS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS.md)
- **Decision Date:** Feb 18, 1992
- **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/K920230](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLS/K920230)

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