Vitros Immunodiagnostics Products Free T4 Reagent Pack (GEM.1015) Free T4 Calibrators (GEM.CO15)

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

510(k) Number

K965142 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Vitros Immunodiagnostics Products/Ck-Mb Reagent Pack(GEM.1300)/Ck-Mb Calibrators (GEM.C300)

  Class I

  FDA 510(k) K973030 Active Cleared 4 Sep 1997

• Vitros Immunodiagnostics Products Lh Reagent Pack (GEM.1055) and Lh Calibrators (GEM.CO55) Open recall

  Class I

  FDA 510(k) K964982 Active Cleared 20 Feb 1997

• Ektachem Dt Ldl Cholesterol Kit

  Class I

  FDA 510(k) K955904 Active Cleared 24 May 1996

• Vitros Immunodiagnostic Products Range Verifiers

  Class I

  FDA 510(k) K973517 Active Cleared 25 Sep 1997

• Ektachem Clinical Chemistry Calcium (Ca) Slide

  Class II

  FDA 510(k) K961226 Active Cleared 7 May 1996

• Amerlite Ferritin II Assay

  Class II

  FDA 510(k) K952286 Active Cleared 20 Jun 1995

See all devices from Johnson & Johnson Clinical Diagnostics, Inc. →

• What is the Vitros Free T4 Reagent Pack used for?

  The Vitros Free T4 Reagent Pack is used for the quantitative measurement of free thyroxine in human serum, aiding in the differential diagnosis of thyroid disease.

• How is the device supplied?

  The device is supplied as a reagent pack and calibrators, intended for in vitro use with the Vitros ECi/ECiQ/3600 Immunodiagnostic Systems and the Vitros 5600/XT 7600 Integrated Systems.

• Is the device cleared by the FDA?

  Yes, the device has been cleared by the FDA with a 510K clearance, classified as a Class 2 device with the regulation number 862.1695.

• What settings is the device used in?

  The device is used in clinical chemistry settings.