← Product Code [JHG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG) · K790798

# FETAL MATURITY TEST PROCEDURE (K790798)

_Helena Laboratories · JHG · Jun 5, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K790798

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JHG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG.md)
- **Decision Date:** Jun 5, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1455
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K790798](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHG/K790798)

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