Enzym-Linked T3

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K820763 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Enzyme-Test Tbc T4 Uptake

  Class II

  FDA 510(k) K820879 Active Cleared 16 Apr 1982

• Antithrombin III Serum, Anti-Human

  Class II

  FDA 510(k) K781026 Active Cleared 10 Aug 1978

• Ceruoplasmin Serum Anti-Human

  Class II

  FDA 510(k) K781024 Active Cleared 14 Aug 1978

• Enzymune System I

  Class I

  FDA 510(k) K822465 Active Cleared 14 Sep 1982

• Enzymune-Test TSH

  Class II

  FDA 510(k) K832823 Active Cleared 14 Oct 1983

• Kova Trol III

  Class I

  FDA 510(k) K780482 Active Cleared 3 May 1978

See all devices from Icl Scientific →

• What is the primary use of the Enzym-Linked T3?

  The Enzym-Linked T3 is a radioimmunoassay device specifically designed for the measurement of total triiodothyronine in a clinical laboratory setting.

• What is the regulatory status of this device?

  This device is classified as a clinical chemistry device and is regulated under 21 CFR 862.1710. It received FDA 510(k) clearance under the number K820763.

• Who is the manufacturer of the Enzym-Linked T3?

  The Enzym-Linked T3 is manufactured by Icl Scientific, located in McHenry, Illinois.