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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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21 to 30 of 49 Results
productcode LOM PMA Number p Decision Date From 1/1/2009 Decision Date To 1/1/2010
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PMA
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ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATOR... Abbott Laboratories P060007 S002 07/13/2009
ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CO... Abbott Laboratories P060035 S001 06/23/2009
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAG... Ortho-Clinical Diagnostics, In P030026 S018 06/12/2009
ADVIA CENTAUR ANTI-HBS (AHBS) SIEMENS HEALTHCARE DIAGNOSTICS P030029 S004 06/10/2009
ABBOTT ARCHITECT HBSAG Abbott Laboratories P060007 S003 06/05/2009
IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE ... Siemens Healthcare Diagnostics P010050 S008 06/02/2009
ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P030049 S006 05/27/2009
ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRA... Abbott Laboratories P080023 04/10/2009
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBR... SIEMENS HEALTHCARE DIAGNOSTICS P030029 S005 04/09/2009
ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY ... SIEMENS HEALTHCARE DIAGNOSTICS P030040 S004 04/09/2009
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