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Ubi Magiwel Thyroxine (T4) Quantitative

by United Biotech, Inc.

510(k) K962211

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962211 Date8 Jul 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KLI
Device Class
Class II
Regulation
21 CFR Part 862.1700
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Ubi Magiwel Thyroxine (T4) Quantitative is an enzyme immunoassay, non-radiolabeled, total thyroxine device. It is used for quantitative measurement of thyroxine in serum and plasma. The device is classified as a clinical chemistry device.

The device is supplied by United Biotech, Inc. and has been cleared under FDA 510(k) with clearance number K962211. It is intended for use in clinical chemistry settings and is regulated under 21 CFR 862.1700. The device is a non-radiolabeled, in vitro diagnostic device.

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