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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 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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IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ... Siemens Healthcare Diagnostics P010052 S004 12/16/2009
ABBOTT ARCHITECT CORE ASSAY Abbott Laboratories P080023 S001 12/10/2009
VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK... Ortho-Clinical Diagnostics, In P000044 S020 10/23/2009
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S022 10/20/2009
ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA... SIEMENS HEALTHCARE DIAGNOSTICS P030040 S002 10/20/2009
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADV... SIEMENS HEALTHCARE DIAGNOSTICS P040004 S002 10/20/2009
ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS SIEMENS HEALTHCARE DIAGNOSTICS P030049 S002 09/25/2009
ADVIA CENTAUR AHBS ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P030029 S008 09/15/2009
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT ... ORTHO-CLINICAL DIAGNOSTICS P030024 S010 09/11/2009
ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI - HBS SIEMENS HEALTHCARE DIAGNOSTICS P030029 S006 08/20/2009
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