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T-3 Uptake Kit

by Diagnostic Products Corp.

510(k) K760802

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760802 Date29 Oct 1976ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KHQ
Device Class
Class II
Regulation
21 CFR Part 862.1715
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The T-3 Uptake Kit is a radioassay device for measuring triiodothyronine (T3) uptake, classified under Clinical Chemistry. It is a substantially equivalent device cleared via the traditional 510(k) pathway.

The device is supplied as a kit for in vitro diagnostic use in clinical laboratories. It has FDA 510(k) clearance (K760802), product code KHQ, and is classified as a Class II medical device under regulation number 862.1715.

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