← Product Code [CEC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC) · K840901

# PHASE II FREE T4 KIT (K840901)

_Medical & Scientific Designs, Inc. · CEC · Apr 25, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC/K840901

## Device Facts

- **Applicant:** Medical & Scientific Designs, Inc.
- **Product Code:** [CEC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC.md)
- **Decision Date:** Apr 25, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1695
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC/K840901](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC/K840901)

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