← Product Code [CGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ) · K760373

# RADIOASSAY KIT, IM.72 FSH (K760373)

_Amersham Corp. · CGJ · Nov 1, 1976 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K760373

## Device Facts

- **Applicant:** Amersham Corp.
- **Product Code:** [CGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ.md)
- **Decision Date:** Nov 1, 1976
- **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/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K760373](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K760373)

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