← Product Code [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW) · K961650

# NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT (K961650)

_Nichols Institute Diagnostics · JLW · Jul 16, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K961650

## Device Facts

- **Applicant:** Nichols Institute Diagnostics
- **Product Code:** [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW.md)
- **Decision Date:** Jul 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1690
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K961650](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K961650)

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