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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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41 to 50 of 127 Results
productcode LOM PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
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Device
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PMA
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ETI-CORE-IGMK PLUS ASSAY DIASORIN, INC. P990044 S014 11/30/2012
ETI-AB-COREK PLUS ASSAY DIASORIN, INC. P990045 S014 11/30/2012
ARCHITECT AUSAB ABBOTT LABORATORIES INC P050051 S016 11/27/2012
ARCHITECT HBSAG/CONFIMATORY Abbott Laboratories P060007 S022 11/27/2012
ARCHITECT CORE-M Abbott Laboratories P060035 S015 11/27/2012
ARCHITECT CORE Abbott Laboratories P080023 S016 11/27/2012
ARCHITECT HBSAG QUALITATIVE/CONFIMATORY Abbott Laboratories P110029 S007 11/27/2012
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PAC... Ortho-Clinical Diagnostics, In P090028 S005 11/26/2012
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT ... ORTHO-CLINICAL DIAGNOSTICS P100001 S004 11/19/2012
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY Abbott Laboratories P110029 S006 11/19/2012
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