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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 4 of 4 Results
510(K) Number: K963926
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Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with ... 2 03/26/2003 Abbott Laboratories HPD/ADD
CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determin... 2 03/26/2003 Abbott Laboratories HPD/ADD
CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagent... 3 07/18/2006 Abbott Laboratories MPG
AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Laboratories, ... 2 07/11/2007 Abbott Laboratories
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