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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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IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Conf... Siemens Healthcare Diagnostics P010050 S021 10/14/2022
IMMULITE® 2000 Anti-HBs Siemens Healthcare Diagnostics P010052 S016 10/14/2022
IMMULITE® 2000 Anti-HBc IgM Siemens Healthcare Diagnostics P010053 S016 10/14/2022
IMMULITE® 2000 Anti-HBc Siemens Healthcare Diagnostics P010051 S017 10/14/2022
IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG ... Siemens Healthcare Diagnostics P010050 S006 12/16/2008
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ... Siemens Healthcare Diagnostics P010052 S004 12/16/2009
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS Siemens Healthcare Diagnostics P010052 S005 12/16/2008
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS Siemens Healthcare Diagnostics P010052 S003 11/02/2005
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ... Siemens Healthcare Diagnostics P010053 S003 11/02/2005
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ... Siemens Healthcare Diagnostics P010053 S004 12/16/2008
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