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Imx Free T3 Calculation

by Abbott Laboratories 510(k)

Active United States

510(k) K903432

Overview

The IMX FREE T3 CALCULATION is a device used for radioimmunoassay of total triiodothyronine in clinical chemistry applications. It is designed to calculate free T3 levels in patient samples.

This device is manufactured by Abbott Laboratories and received FDA 510(k) clearance on September 7, 1990, with the K903432 number. It is classified as a Class 2 device under regulation 862.1710 and is intended for use in clinical chemistry settings.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903432 Date7 Sep 1990ClearedStatusActive

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
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, 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 IMX FREE T3 Calculation device used for?

    The IMX FREE T3 Calculation device is used for radioimmunoassay of total triiodothyronine in clinical chemistry applications. It is specifically designed to calculate free T3 levels in patient samples for diagnostic purposes.

  • What is the regulatory status of the IMX FREE T3 Calculation device?

    The IMX FREE T3 Calculation device received FDA 510(k) clearance on September 7, 1990, with the K903432 number. It is classified as a Class 2 device under regulation 862.1710 and is intended for use in clinical chemistry settings.

  • Who manufactures the IMX FREE T3 Calculation device?

    The IMX FREE T3 Calculation device is manufactured by Abbott Laboratories, a company headquartered at One Abbott Park Rd., Abbott Park, IL 60064. The device was developed for clinical chemistry applications to measure free T3 levels in patient samples.

  • What is the product code and classification of the IMX FREE T3 Calculation device?

    The IMX FREE T3 Calculation device has a product code of CDP and is classified as a Class 2 device under regulation 862.1710. It is intended for radioimmunoassay of total triiodothyronine in clinical chemistry applications.