← Product Code [CEC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC) · K903383

# TDX FREE T4 CALCULATION (K903383)

_Abbott Laboratories · CEC · Sep 10, 1990 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC/K903383

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [CEC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC.md)
- **Decision Date:** Sep 10, 1990
- **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/K903383](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC/K903383)

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