Vitros Chemistry Products Dhdl Slides

• • Terminated Z-0311-2014 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

K120609 ↗

FDA Product Code

LBS

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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