Easytouch Tromboplastin Reagent

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

510(k) Number

K832427 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Easytouch Hemoglobin Reagent

  Class II

  FDA 510(k) K832750 Active Cleared 26 Sep 1983

• Easytouch Bun Reagent Set

  Class II

  FDA 510(k) K832749 Active Cleared 14 Oct 1983

• Tia-Iga Reagent & Calibrator Sets

  Class II

  FDA 510(k) K831102 Active Cleared 27 Apr 1983

• Szamyl 6.5

  Class II

  FDA 510(k) K790474 Active Cleared 1 May 1979

• Worthington Triglycerides Reagent Set

  Class I

  FDA 510(k) K791962 Active Cleared 5 Nov 1979

• Serum T4 by Enzyme Immunoassay

  Class II

  FDA 510(k) K802573 Active Cleared 24 Nov 1980

See all devices from Worthington Diagnostic Systems →

• What is the EASYTOUCH TROMBOPLASTIN REAGENT used for?

  The EASYTOUCH TROMBOPLASTIN REAGENT is used as a Test, Time, Prothrombin reagent in hematology testing to measure prothrombin time, which evaluates the extrinsic pathway of blood coagulation in vitro.

• How is the EASYTOUCH TROMBOPLASTIN REAGENT supplied and for what purpose?

  The reagent is supplied for in vitro diagnostic use by Worthington Diagnostic Systems in McHenry, Illinois, and is intended for laboratory testing of blood samples to assess clotting function.

• What regulatory pathway was used to clear the EASYTOUCH TROMBOPLASTIN REAGENT?

  The EASYTOUCH TROMBOPLASTIN REAGENT was cleared via the FDA 510(k) pathway under submission K832427 on October 14, 1983, following a traditional review process and found to be substantially equivalent to a predicate device.