Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139

• • Terminated Z-1145-2010 FDA Unclassified (pre-2012) ·initiated 14 Jul 2009 ·on shared 510(k) K032868

  The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.

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

510(k) Number

K032868 ↗

FDA Product Code

MID

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Reaads Igg Anti-Prothrombin Semi-Quantitative Test Kit

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  Class II

  FDA 510(k) K022992 Active Cleared 25 Sep 2002

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  FDA 510(k) K042680 Active Cleared 19 Nov 2004

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