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Total T3 Chemiluminescence Assay

by Nichols Institute Diagnostics 510(k)

Active United States

510(k) K923015

Overview

The Total T3 Chemiluminescence Assay is a radioimmunoassay device used for the measurement of total triiodothyronine in clinical samples. It is designed to assist in the assessment of thyroid function by quantifying the levels of this specific hormone.

This device has received FDA 510(k) clearance under the product code CDP. It is intended for use within a clinical chemistry setting for diagnostic testing purposes.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923015 Date2 Sep 1992ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CDP
Device Class
Class II
Regulation
21 CFR Part 862.1710
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the Total T3 Chemiluminescence Assay?

    This device is a radioimmunoassay designed for the measurement of total triiodothyronine in clinical samples. It is used by clinicians to assist in the assessment of thyroid function by quantifying hormone levels.

  • In what environment is this assay intended to be used?

    The assay is intended for use within a clinical chemistry setting. It is designed for diagnostic testing purposes to support clinical evaluations of thyroid health.

  • Has this device received regulatory authorization?

    Yes, the Total T3 Chemiluminescence Assay has received FDA 510(k) clearance. It is classified under product code CDP and regulation number 862.1710 for its use as a radioimmunoassay for total triiodothyronine.