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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 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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AXSYM AUSAB (LN 3C74) ABBOTT LABORATORIES INC P060003 S006 10/19/2010
AXSYM CORE-M 2.0 (LN 8B89) ABBOTT LABORATORIES INC P060009 S002 10/19/2010
AXSYM CORE 2.0 (LN 8B88) ABBOTT LABORATORIES INC P060012 S004 10/19/2010
ADVIA ANTI-HBS ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P030029 S011 10/18/2010
BIO-RAD MONOLISA ANTI -HBS EIA BIO-RAD LABORATORIES P050048 S006 09/27/2010
ADVIA CENTAUR ANTI-HBS (AHBS) SIEMENS HEALTHCARE DIAGNOSTICS P030029 S009 09/01/2010
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S024 08/30/2010
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT ... Ortho-Clinical Diagnostics, In P000014 S021 08/19/2010
BIO-RAD MONOLISA ANTI-HBC IGM EIA Bio-Rad Laboratories, Inc. P060034 S004 08/02/2010
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITA... Ortho-Clinical Diagnostics, In P000014 S020 07/16/2010
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