← Product Code [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW) · K003752

# BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) (K003752)

_Biosafe Laboratories, Inc. · JLW · Mar 23, 2001 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K003752

## Device Facts

- **Applicant:** Biosafe Laboratories, Inc.
- **Product Code:** [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW.md)
- **Decision Date:** Mar 23, 2001
- **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/K003752](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K003752)

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