← Product Code [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW) · K862428

# STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY (K862428)

_American Dade · JLW · Aug 19, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K862428

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW.md)
- **Decision Date:** Aug 19, 1986
- **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/K862428](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K862428)

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