← Product Code [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL) · K912858

# LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (K912858)

_London Diagnostics, Inc. · CFL · Jul 30, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K912858

## Device Facts

- **Applicant:** London Diagnostics, Inc.
- **Product Code:** [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL.md)
- **Decision Date:** Jul 30, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1370
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K912858](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K912858)

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