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T3 Ria (Peg) Diagnostic Kit

by Abbott Laboratories 510(k)

Active United States

510(k) K770201

Overview

The T3 Ria (Peg) Diagnostic Kit is a radioimmunoassay device for measuring Total Triiodothyronine. It is classified as a diagnostic kit and is used in clinical chemistry applications.

The device is supplied as a diagnostic kit and is intended for use in a clinical setting. It has been cleared by the FDA under the traditional clearance type, with a decision code of SESE, and is classified as a class 2 device with the regulation number 862.1710.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770201 Date5 Apr 1977ClearedStatusActive

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 T3 Ria Diagnostic Kit used for?

    The T3 Ria Diagnostic Kit is used to measure Total Triiodothyronine in clinical chemistry applications, providing diagnostic results in a clinical setting.

  • Is the T3 Ria Diagnostic Kit cleared by the FDA?

    Yes, the T3 Ria Diagnostic Kit has been cleared by the FDA under the traditional clearance type with a decision code of SESE, and is classified as a class 2 device.

  • What type of device is the T3 Ria Diagnostic Kit?

    The T3 Ria Diagnostic Kit is a radioimmunoassay device, specifically designed for diagnostic purposes in clinical chemistry applications.

  • How is the T3 Ria Diagnostic Kit supplied?

    The T3 Ria Diagnostic Kit is supplied as a diagnostic kit, intended for use in a clinical setting.