← Product Code [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW) · K854087

# NML TSH IRMA (K854087)

_Organon Teknika Corp. · JLW · Oct 25, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K854087

## Device Facts

- **Applicant:** Organon Teknika Corp.
- **Product Code:** [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW.md)
- **Decision Date:** Oct 25, 1985
- **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/K854087](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K854087)

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