← Product Code [CGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ) · K831742

# QUANTIMUNE HFSH RIA HUMAN FOLLICLE- (K831742)

_Bio-Rad · CGJ · Jul 18, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K831742

## Device Facts

- **Applicant:** Bio-Rad
- **Product Code:** [CGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ.md)
- **Decision Date:** Jul 18, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1300
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K831742](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K831742)

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