Micro Thyroxine Reagent System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K781182 ↗

FDA Product Code

CDX

Device Class

Class II

Regulation

21 CFR Part 862.1700

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Micro Thyroxine Reagent System used for?

  The Micro Thyroxine Reagent System is used for radioimmunoassay of total thyroxine in clinical chemistry laboratories to measure thyroxine levels in patient samples for diagnostic purposes.

• How is the Micro Thyroxine Reagent System supplied and is it single-use?

  The device is supplied as a reagent system and is intended for single-use in laboratory settings, meaning it is designed to be used once and then discarded to prevent cross-contamination and ensure test accuracy.

• What regulatory pathway was used for the Micro Thyroxine Reagent System?

  The Micro Thyroxine Reagent System received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device, and is classified as a Class II device under product code CDX.