Phase II Free T4 Kit

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

510(k) Number

K840901 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K830642 Active Cleared 5 Apr 1983

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  Class I

  FDA 510(k) K830365 Active Cleared 10 Mar 1983

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  Class I

  FDA 510(k) K832209 Active Cleared 24 Aug 1983

• Phase II Ferritin Radioimmunoassay Kit

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  FDA 510(k) K862960 Active Cleared 27 Aug 1986

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  Class II

  FDA 510(k) K832499 Active Cleared 12 Sep 1983

• Uptake T3 Radioimmunoassay Kit

  Class II

  FDA 510(k) K830900 Active Cleared 18 Apr 1983

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• What is the primary purpose of the Phase II Free T4 Kit?

  This device is a radioimmunoassay tool designed for the measurement of free thyroxine. It is utilized within clinical chemistry to assist in the assessment of thyroid function.

• What is the regulatory status of this device?

  The Phase II Free T4 Kit has received FDA 510(k) clearance under regulation number 862.1695. It was determined to be substantially equivalent to existing devices during the review process.

• Which medical specialty is this kit associated with?

  The device is categorized under the clinical chemistry medical specialty, as it is used for diagnostic laboratory testing related to thyroid hormone levels.