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Siemens Healthcare Diagnostics Products, Ltd.

69 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit (P010050/S026)Siemens Healthcare Diagnostics Products, Ltd.2025-09-18
IMMULITE 2000 Total Antibodies to Hepatitis B Surface Antigen (Anti-HBs) (P010052/S020)Siemens Healthcare Diagnostics Products, Ltd.2025-09-18
IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit (P010050/S025)Siemens Healthcare Diagnostics Products, Ltd.2025-09-18
IMMULITE 2000 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc) (P010051/S023)Siemens Healthcare Diagnostics Products, Ltd.2025-08-04
IMMULITE® 2000 HBsAg, IMMULITE® 2000 HBsAg Confirmatory (P010050/S020)Siemens Healthcare Diagnostics Products, Ltd.2023-08-30
IMMULITE® 2000 Anti-HBs (P010052/S015)Siemens Healthcare Diagnostics Products, Ltd.2023-08-30
IMMULITE® 2000 Anti-HBc IgM (P010053/S015)Siemens Healthcare Diagnostics Products, Ltd.2023-08-30
IMMULITE® 2000 Anti HBc (P010051/S016)Siemens Healthcare Diagnostics Products, Ltd.2023-08-30
IMMULITE® 2000 Anti-HBs (P010052/S016)Siemens Healthcare Diagnostics Products, Ltd.2022-10-14
IMMULITE® 2000 Anti-HBc (P010051/S017)Siemens Healthcare Diagnostics Products, Ltd.2022-10-14
IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit’ (P010050/S021)Siemens Healthcare Diagnostics Products, Ltd.2022-10-14
IMMULITE® 2000 Anti-HBc IgM (P010053/S016)Siemens Healthcare Diagnostics Products, Ltd.2022-10-14
IMMULITE 2000 Anti-HBc (P010051/S015)Siemens Healthcare Diagnostics Products, Ltd.2022-03-29
IMMULITE 2000 Anti-HBc IgM (P010053/S014)Siemens Healthcare Diagnostics Products, Ltd.2022-03-29
IMMULITE 2000 HBs Ag Confirmatory (P010050/S019)Siemens Healthcare Diagnostics Products, Ltd.2021-06-09
IMMULITE 2000/2000 XPi Anti-HBc IgM (P010053/S013)Siemens Healthcare Diagnostics Products, Ltd.2021-03-11
IMMULITE 2000/2000 XPi Anti-HBc (P010051/S014)Siemens Healthcare Diagnostics Products, Ltd.2021-03-11
IMMULITE 2000 HBsAg Confirmatory (P010050/S018)Siemens Healthcare Diagnostics Products, Ltd.2020-09-08
IMMULITE 2000 Anti-HBcM (P010053/S012)Siemens Healthcare Diagnostics Products, Ltd.2020-09-08
IMMULITE 2000 Anti-HBs (P010052/S014)Siemens Healthcare Diagnostics Products, Ltd.2020-09-08
IMMULITE 2000 Anti-HBc (P010051/S013)Siemens Healthcare Diagnostics Products, Ltd.2020-09-08
IMMULITE 2000 Anti HBc IgM (P010053/S011)Siemens Healthcare Diagnostics Products, Ltd.2019-12-19
IMMULITE 2000 Anti-HBc (P010051/S012)Siemens Healthcare Diagnostics Products, Ltd.2019-12-19
IMMULITE 2000 Anti-HBs (P010052/S013)Siemens Healthcare Diagnostics Products, Ltd.2019-12-19
IMMULITE 2000 HBsAg & HBs Ag Confirmatory (P010050/S017)Siemens Healthcare Diagnostics Products, Ltd.2019-12-19
IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS (P010052/S012)Siemens Healthcare Diagnostics Products, Ltd.2015-07-27
IMMULITE HBSAG, IMMULITE 2000 HBSAG (P010050/S016)Siemens Healthcare Diagnostics Products, Ltd.2014-11-18
HBSAG IMMULITE SUBSTRATE REAGENT (P010050/S015)Siemens Healthcare Diagnostics Products, Ltd.2012-03-27
ANTI-HBS IMMULITE SUBSTRATE REAGENT (P010052/S011)Siemens Healthcare Diagnostics Products, Ltd.2012-03-27
ANTI-HBCM IMMULITE SUBSTRATE REAGENT (P010053/S010)Siemens Healthcare Diagnostics Products, Ltd.2012-03-27
ANTI-HBC IMMULITE SUBSTRATE REAGENT (P010051/S011)Siemens Healthcare Diagnostics Products, Ltd.2012-03-27
IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY (P010050/S014)Siemens Healthcare Diagnostics Products, Ltd.2011-09-13
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS (P010052/S010)Siemens Healthcare Diagnostics Products, Ltd.2011-09-13
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010053/S009)Siemens Healthcare Diagnostics Products, Ltd.2011-09-13
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010051/S010)Siemens Healthcare Diagnostics Products, Ltd.2011-09-13
ANTI-HBS IMMULITE ASSAY (P010052/S009)Siemens Healthcare Diagnostics Products, Ltd.2011-09-02
ANTI-HBC IMMULITE ASSAY (P010051/S009)Siemens Healthcare Diagnostics Products, Ltd.2011-09-02
ANTI-HBCM IMMULITE ASSAY (P010053/S008)Siemens Healthcare Diagnostics Products, Ltd.2011-09-02
HBSAG IMMULITE ASSAY (P010050/S013)Siemens Healthcare Diagnostics Products, Ltd.2011-09-02
IMMULITE 2000 HBS AG CONFIRMATORY KIT (P010050/S011)Siemens Healthcare Diagnostics Products, Ltd.2011-06-24
ANTI-HBC (P010051/S008)Siemens Healthcare Diagnostics Products, Ltd.2011-05-12
ANTI-HBS (P010052/S008)Siemens Healthcare Diagnostics Products, Ltd.2011-05-12
HBSAG (P010050/S012)Siemens Healthcare Diagnostics Products, Ltd.2011-05-12
ANTI-HBC IGM (P010053/S007)Siemens Healthcare Diagnostics Products, Ltd.2011-05-12
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010051/S007)Siemens Healthcare Diagnostics Products, Ltd.2010-01-20
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM (P010053/S006)Siemens Healthcare Diagnostics Products, Ltd.2010-01-20
IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS (P010052/S007)Siemens Healthcare Diagnostics Products, Ltd.2010-01-20
IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY (P010050/S010)Siemens Healthcare Diagnostics Products, Ltd.2010-01-20
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS (P010052/S004)Siemens Healthcare Diagnostics Products, Ltd.2009-12-16
IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY (P010050/S008)Siemens Healthcare Diagnostics Products, Ltd.2009-06-02
IMMULITE & IMMULITE 2000 HBSAG ASSAY (P010050/S007)Siemens Healthcare Diagnostics Products, Ltd.2009-02-09
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS (P010052/S005)Siemens Healthcare Diagnostics Products, Ltd.2008-12-16
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM (P010053/S004)Siemens Healthcare Diagnostics Products, Ltd.2008-12-16
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC (P010051/S005)Siemens Healthcare Diagnostics Products, Ltd.2008-12-16
IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY (P010050/S006)Siemens Healthcare Diagnostics Products, Ltd.2008-12-16
IMMULITE / IMMULITE 1000 HBSAG & IMMULITE 2000 HBSAG (P010050/S005)Siemens Healthcare Diagnostics Products, Ltd.2006-09-01
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS (P010051/S004)Siemens Healthcare Diagnostics Products, Ltd.2006-06-16
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC (P010051/S003)Siemens Healthcare Diagnostics Products, Ltd.2005-11-02
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS (P010052/S003)Siemens Healthcare Diagnostics Products, Ltd.2005-11-02
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM (P010053/S003)Siemens Healthcare Diagnostics Products, Ltd.2005-11-02
IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS. (P010050/S003)Siemens Healthcare Diagnostics Products, Ltd.2003-06-11
IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC (P010053/S001)Siemens Healthcare Diagnostics Products, Ltd.2003-03-13
IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS (P010052/S001)Siemens Healthcare Diagnostics Products, Ltd.2003-03-13
IMMULITE,IMMULITE 1000 HBSAG,CONFIRMATORY AND IMMULITE 2000 HBSAG,CONFIRMATORY KIT (P010050/S001)Siemens Healthcare Diagnostics Products, Ltd.2003-03-13
IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM (P010051/S001)Siemens Healthcare Diagnostics Products, Ltd.2003-03-13
IMMULITE 2000 XPI HBSAG (P010050)Siemens Healthcare Diagnostics Products, Ltd.2002-07-26
IMMULITE 2000 XPI ANTI-HBC IMG (P010053)Siemens Healthcare Diagnostics Products, Ltd.2002-07-26
IMMULITE 2000 XPI ANTI-HBC (P010051)Siemens Healthcare Diagnostics Products, Ltd.2002-07-24
IMMULITE 2000 XPI ANTI-HBS (P010052)Siemens Healthcare Diagnostics Products, Ltd.2002-07-22

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Every clearance here is in the API, with alerts when new ones post.