Vitros Chemistry Products Crp Slide and Calibrator Kit 7

• • Terminated Z-0309-2014 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.

• • Terminated Z-0387-05 FDA Unclassified (pre-2012) ·initiated 22 Nov 2004

  Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.

• • Terminated Z-1473-04 FDA Unclassified (pre-2012) ·initiated 28 Jul 2004

  The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.

510(k) Number

K030626 ↗

FDA Product Code

DCK

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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