Strat Total Thyroxine Fluoromet Enzyme Immunoassay

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K860421 ↗

FDA Product Code

CDX

Device Class

Class II

Regulation

21 CFR Part 862.1700

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Creatine Kinase Mb Reagent

  Class II

  FDA 510(k) K840783 Active Cleared 4 Apr 1984

• Stratus Phenytoin Fluorometric Enzyme

  Class II

  FDA 510(k) K831154 Active Cleared 16 May 1983

• Lactate Reagent

  Class I

  FDA 510(k) K840778 Active Cleared 13 Apr 1984

• Paramax Iron Blank Reagent

  Class I

  FDA 510(k) K841887 Active Cleared 22 Jun 1984

• Immu-Trace T3 Uptake (T3U) Reagents

  Class II

  FDA 510(k) K803044 Active Cleared 2 Jan 1981

• Uric Acid Reagent

  Class I

  FDA 510(k) K840781 Active Cleared 13 Apr 1984

See all devices from American Dade →

• What is the Strat Total Thyroxine Fluoromet Enzyme Immunoassay used for?

  This device is a radioimmunoassay designed to measure total thyroxine levels in clinical specimens. It is used in clinical chemistry laboratories to assess thyroid function by quantifying the total concentration of thyroxine hormone present in patient samples.

• What regulatory pathway was used for the Strat Total Thyroxine Fluoromet Enzyme Immunoassay?

  The device obtained FDA 510(k) clearance under submission number K860421, demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class II medical device under regulation 862.1700 for radioimmunoassay systems measuring total thyroxine.

• Who manufactures the Strat Total Thyroxine Fluoromet Enzyme Immunoassay and where are they located?

  The device is manufactured by American Dade, located in Santa Ana, California. The applicant information on file shows their address as P.O. Box 25101, Santa Ana, CA 92799, with contact person Karen H. Darcy listed in the submission records.