← Product Code [CEC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC) · K944697

# AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK (K944697)

_Organon Teknika Corp. · CEC · Feb 22, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC/K944697

## Device Facts

- **Applicant:** Organon Teknika Corp.
- **Product Code:** [CEC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC.md)
- **Decision Date:** Feb 22, 1995
- **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/K944697](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEC/K944697)

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