← Product Code [JLX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX) · K934178

# ACCUSCREEN 17-HYDROXYPROGESTERONE (K934178)

_Neometrics, Inc. · JLX · Mar 30, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K934178

## Device Facts

- **Applicant:** Neometrics, Inc.
- **Product Code:** [JLX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX.md)
- **Decision Date:** Mar 30, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1395
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K934178](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K934178)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com