Dimension Ctni Flex Reagent Cartridge

• • Terminated Z-1731-2009 FDA Unclassified (pre-2012) ·initiated 8 Apr 2008

  possibility of falsely elevated results

• • Terminated Z-0858-2010 FDA Unclassified (pre-2012) ·initiated 2 Mar 2007

  Tests exhibit falsely elevated results.

510(k) Number

K010313 ↗

FDA Product Code

MMI

Device Class

Class II

Regulation

21 CFR Part 862.1215

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 I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

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