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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant SIEMENS HEALTHCARE DIAGNOSTICS productcode LOM Decision Date To 05/04/2024
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ANTI-HBCM IMMULITE SUBSTRATE REAGENT Siemens Healthcare Diagnostics P010053 S010 03/27/2012
ADVIA CENTAUR HBC TOTAL ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P040004 S008 02/03/2012
ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY ... SIEMENS HEALTHCARE DIAGNOSTICS P100039 01/20/2012
ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATE... SIEMENS HEALTHCARE DIAGNOSTICS P090024 10/11/2011
IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 200... Siemens Healthcare Diagnostics P010050 S014 09/13/2011
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC Siemens Healthcare Diagnostics P010051 S010 09/13/2011
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS Siemens Healthcare Diagnostics P010052 S010 09/13/2011
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC Siemens Healthcare Diagnostics P010053 S009 09/13/2011
HBSAG IMMULITE ASSAY Siemens Healthcare Diagnostics P010050 S013 09/02/2011
ANTI-HBC IMMULITE ASSAY Siemens Healthcare Diagnostics P010051 S009 09/02/2011
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