Centria T4 RIA Test Set

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

510(k) Number

K790800 ↗

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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See all devices from Ventrex Laboratories, Inc. →

• What is the Centria T4 RIA Test Set used for?

  The Centria T4 RIA Test Set is a radioimmunoassay device designed to measure total thyroxine (T4) levels in patient samples. It is intended for use in clinical laboratory settings to support thyroid function testing as part of diagnostic evaluation.

• How is the Centria T4 RIA Test Set supplied and is it sterile or single-use?

  The device is supplied by Ventrex Laboratories, Inc. as a test kit for laboratory use. The provided data does not specify sterility or single-use status, so users should consult the product labeling for details on handling, storage, and whether components are intended for single or multiple use.

• What regulatory pathway was used for the Centria T4 RIA Test Set and what is its classification?

  The Centria T4 RIA Test Set received FDA 510(k) clearance through the traditional pathway under submission K790800. It is classified as a Class II device with product code CDX and regulation number 862.1700, indicating substantial equivalence to a legally marketed predicate device.