Ektachem Clinical Chemistry Slide for Acetaminophen

• • Terminated Z-0292-2014 FDA Class II ·initiated 12 Jun 2013

  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

510(k) Number

K954933 ↗

FDA Product Code

LDP

Device Class

Class II

Regulation

21 CFR Part 862.3030

Advisory Committee

Clinical Toxicology

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

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

  Class II

  FDA 510(k) K965142 Active Cleared 18 Mar 1997

• Ektachem Clinical Chemistry Calcium (Ca) Slide

  Class II

  FDA 510(k) K961226 Active Cleared 7 May 1996

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