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Tbg Diagnostic Kit

by Diagnostic Reagents, Inc.

510(k) K820252

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 NumberK820252 Date5 May 1982ClearedStatusActive

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  • Withdrawn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
CEE
Device Class
Class II
Regulation
21 CFR Part 862.1685
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Tbg Diagnostic Kit is a radioimmunoassay device for measuring Thyroxine-Binding Globulin. It is classified as a Clinical Chemistry device. The kit is used for diagnostic purposes, specifically for the determination of Thyroxine-Binding Globulin levels.

The Tbg Diagnostic Kit is supplied with a product code of CEE and is regulated under the regulation number 862.1685. It has been cleared by the FDA with a 510K clearance, specifically with the k number K820252. The device is intended for use in a clinical setting and is classified as a class 2 device.

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Questions

AI-generated answers, 26 Sep 2026

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

  • What is the TBG Diagnostic Kit used for?

    The TBG Diagnostic Kit is used for diagnostic purposes, specifically for the determination of Thyroxine-Binding Globulin levels in a clinical setting.

  • Is the TBG Diagnostic Kit cleared by the FDA?

    Yes, the TBG Diagnostic Kit has been cleared by the FDA with a 510K clearance, specifically with the k number K820252, indicating it is substantially equivalent to a predicate device.

  • What type of device is the TBG Diagnostic Kit?

    The TBG Diagnostic Kit is a radioimmunoassay device, classified as a Clinical Chemistry device, and is regulated under the regulation number 862.1685.

  • What is the product code for the TBG Diagnostic Kit?

    The product code for the TBG Diagnostic Kit is CEE.