Skip to content

Reagent, RIA Triiodothyronine T3 (#200)

by Oxford Laboratories, Inc. 510(k)

Active United States

510(k) K760078

Overview

This is a radioimmunoassay reagent used for the quantitative measurement of total triiodothyronine (T3) levels in clinical laboratory settings. The device is designed to assist in the diagnosis and monitoring of thyroid disorders by providing accurate T3 concentration measurements.

The reagent is supplied as a laboratory test kit and is intended for single-use in clinical chemistry laboratories. It is a Class II medical device cleared by the FDA under product code CDP, with FDA 510(k) clearance K760078 granted on July 20, 1976. The device is not MRI compatible and should be stored according to the manufacturer's instructions.

AI-generated from registry data, 21 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 NumberK760078 Date20 Jul 1976ClearedStatusActive

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

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

Other devices from Oxford Laboratories, Inc.

See all devices from Oxford Laboratories, Inc. →

Questions

  • What is the REAGENT, RIA TRIIODOTHYRONINE T3 (#200) used for?

    This radioimmunoassay reagent is used for the quantitative measurement of total triiodothyronine (T3) levels in clinical laboratory settings to assist in the diagnosis and monitoring of thyroid disorders.

  • How is the REAGENT, RIA TRIIODOTHYRONINE T3 (#200) supplied?

    The reagent is supplied as a laboratory test kit intended for single-use in clinical chemistry laboratories. It should be stored according to the manufacturer's instructions and is not MRI compatible.

  • What is the regulatory status of the REAGENT, RIA TRIIODOTHYRONINE T3 (#200)?

    This is a Class II medical device cleared by the FDA under product code CDP, with FDA 510(k) clearance K760078 granted on July 20, 1976. It is substantially equivalent to other devices in this category.

  • Is the REAGENT, RIA TRIIODOTHYRONINE T3 (#200) reusable or single-use?

    The reagent is intended for single-use in clinical chemistry laboratories. After use, it should be disposed of according to laboratory protocols and manufacturer instructions.