← Product Code [JLP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLP) · K872843

# OVEIA (TM) DUAL ANALYTE (K872843)

_Boots-Celltech Diagnostics, Inc. · JLP · Feb 2, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLP/K872843

## Device Facts

- **Applicant:** Boots-Celltech Diagnostics, Inc.
- **Product Code:** [JLP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLP.md)
- **Decision Date:** Feb 2, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1605
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progesterone) in urine. 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/JLP/K872843](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLP/K872843)

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