Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2

• • Terminated Z-0304-2014 FDA Class II ·initiated 12 Jun 2013 ·on shared 510(k) K012593

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K012593 ↗

FDA Product Code

LBR

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

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  Class II

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  Class II

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  Class II

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• Vitros Immunodiagnostic Products 25-Oh Vitamin D Total Reagent Pack, Vitamin D Total Calibrators

  Class II

  FDA 510(k) K121608 Active Cleared 15 Feb 2013

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