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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 46 Results
productcode LOM PMA Number p Decision Date From 1/1/2010 Decision Date To 1/1/2011
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Device
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PMA
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HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT Ortho-Clinical Diagnostics, In P000044 S023 07/16/2010
ANTI-HBC REAGENT PACK AND CALIBRATOR ORTHO-CLINICAL DIAGNOSTICS P030024 S012 07/16/2010
ANTI-HBC REAGENT PACK AND CALIBRATOR Ortho-Clinical Diagnostics, In P030026 S019 07/16/2010
ELECSYS ANTI-HBS CALCHECK ROCHE DIAGNOSTICS CORP. P010054 S012 06/04/2010
AXSYM CORE 2.0 ABBOTT LABORATORIES INC P060012 S002 06/03/2010
ETI-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY ... DIASORIN, INC. P990038 S013 05/21/2010
ETI-AB-EBK PLUS KIT DIASORIN, INC. P990041 S012 05/21/2010
ETI-AB-AUK PLUS KIT DIASORIN, INC. P990042 S009 05/21/2010
ETI-EBK PLUS KIT DIASORIN, INC. P990043 S013 05/21/2010
ETI-COREK-IGMK PLUS KIT DIASORIN, INC. P990044 S010 05/21/2010
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