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Modified Free T4 Radioimmunoassay Kit

by Advanced Magnetics, Inc.

510(k) K884753

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 NumberK884753 Date27 Feb 1989ClearedStatusActive

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  • Withdrawn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
CEC
Device Class
Class II
Regulation
21 CFR Part 862.1695
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 Modified Free T4 Radioimmunoassay Kit is a radioimmunoassay device for the quantitative determination of human thyroxine (T4) in serum or EDTA plasma. It is based on a competitive radioimmunoassay principle, where the sample or calibrator T4 competes with the T4 labeled with Iodine-125 for the specific sites of the anti-serum coated on the tubes.

The kit is supplied for research use only and is not intended for use in diagnostic procedures. It has been cleared by the FDA under the traditional clearance type with the regulation number 862.1695 and has the product code CEC. The device is manufactured by Advanced Magnetics, Inc. and has the k number K884753.

Other devices from Advanced Magnetics, Inc.

Questions

AI-generated answers, 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.

  • What is the Modified Free T4 Radioimmunoassay Kit used for?

    The kit is used for the quantitative determination of human thyroxine in serum or EDTA plasma for research use only, not for diagnostic procedures.

  • Is the Modified Free T4 Radioimmunoassay Kit cleared by the FDA?

    Yes, the kit has been cleared by the FDA under the traditional clearance type with the regulation number 862.1695 and has the product code CEC.

  • What is the intended use of the Modified Free T4 Radioimmunoassay Kit?

    The kit is intended for research use only and is not intended for use in diagnostic procedures.

  • What is the principle of the Modified Free T4 Radioimmunoassay Kit?

    The kit is based on a competitive radioimmunoassay principle, where the sample or calibrator T4 competes with the T4 labeled with Iodine-125 for the specific sites of the anti-serum coated on the tubes.