← Product Code [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL) · K955390

# INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY (K955390)

_Corning Nichols Diagnostics · CFL · Dec 29, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K955390

## Device Facts

- **Applicant:** Corning Nichols Diagnostics
- **Product Code:** [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL.md)
- **Decision Date:** Dec 29, 1995
- **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/K955390](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K955390)

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