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Siemens Healthcare Diagnostics

252 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Dimension Vista TPSA Flex reagent cartridge (P000021/S034)Siemens Healthcare Diagnostics2017-11-14
ADVIA CENTAUR PSA ASSAY (P950021/S014)Siemens Healthcare Diagnostics2017-07-27
Dimension FPSA Flex reagent cartridge (RF451) (P020027/S027)Siemens Healthcare Diagnostics2017-07-17
Dimension TPSA Flex reagent cartridge (RF451) (P000021/S032)Siemens Healthcare Diagnostics2017-07-17
Dimension FPSA Flex reagent cartridge (RF452) (P020027/S026)Siemens Healthcare Diagnostics2017-05-22
Dimension TPSA Flex reagent cartridge (RF451) (P000021/S031)Siemens Healthcare Diagnostics2017-05-22
ADVIA Centaur HBeAg (P090024/S003)Siemens Healthcare Diagnostics2017-04-25
Dimension FPSA Flex reagent cartridge (P020027/S025)Siemens Healthcare Diagnostics2017-03-16
Dimension TPSA Flex reagent cartridge (P000021/S030)Siemens Healthcare Diagnostics2017-03-16
ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040/S011)Siemens Healthcare Diagnostics2016-12-25
ADVIA CENTAUR CPSA ASSAY (P990055/S015)Siemens Healthcare Diagnostics2016-10-24
DIMENSION VISTA TPSA ASSAY (P000021/S028)Siemens Healthcare Diagnostics2016-10-19
DIMENSION VISTA FPSA ASSAY (P020027/S023)Siemens Healthcare Diagnostics2016-10-19
ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY (P090024/S001)Siemens Healthcare Diagnostics2016-10-18
ADVIA Centaur® HCV assay (P030056/S009)Siemens Healthcare Diagnostics2016-09-09
DIMENSION FPSA FLEX REAGENT CARTRIDGE (RF452) (P020027/S024)Siemens Healthcare Diagnostics2016-08-30
DIMENSION TPSA FLEX REAGENT CARTRIDGE (RF451) (P000021/S029)Siemens Healthcare Diagnostics2016-08-30
ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S012)Siemens Healthcare Diagnostics2016-08-11
ADVIA CENTAUR AHBCM ASSAY (P030040/S009)Siemens Healthcare Diagnostics2016-03-11
DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S022)Siemens Healthcare Diagnostics2015-12-15
DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S027)Siemens Healthcare Diagnostics2015-12-15
ADVIA CENTAUR HCV ASSAY (P030056/S010)Siemens Healthcare Diagnostics2015-07-10
ADVIA CENTAUR HBC IGM ASSAY (P030040/S010)Siemens Healthcare Diagnostics2015-07-10
ADVIA CENTAUR HBEAG ASSAY (P090024/S002)Siemens Healthcare Diagnostics2015-07-10
ADVIA CENTAUR HBSAG ASSAY (P030049/S012)Siemens Healthcare Diagnostics2015-07-10
ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S011)Siemens Healthcare Diagnostics2015-07-10
ADVIA CENTAUR HCV READYPACKS (P030056/S008)Siemens Healthcare Diagnostics2015-03-10
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL (P040004/S010)Siemens Healthcare Diagnostics2015-02-27
ADVIA CENTAUR HBSAG (HBS) ASSAY (P030049/S011)Siemens Healthcare Diagnostics2014-10-28
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S026)Siemens Healthcare Diagnostics2014-09-25
DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S021)Siemens Healthcare Diagnostics2014-09-25
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S025)Siemens Healthcare Diagnostics2013-05-28
DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S020)Siemens Healthcare Diagnostics2013-05-28
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S023)Siemens Healthcare Diagnostics2013-02-22
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S019)Siemens Healthcare Diagnostics2012-11-20
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S024)Siemens Healthcare Diagnostics2012-11-20
ADVIA CENTAUR HCV ASSAY (P030056/S007)Siemens Healthcare Diagnostics2012-10-15
ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS (P030049/S010)Siemens Healthcare Diagnostics2012-10-15
ADVIA CENTAUR HBC IGM ASSAY (P030040/S008)Siemens Healthcare Diagnostics2012-10-15
ADVIA CENTAUR ANTI-HBS ASSAY (P030029/S013)Siemens Healthcare Diagnostics2012-10-15
ADVIA CENTAUR CPSA ASSAY (P990055/S014)Siemens Healthcare Diagnostics2012-10-15
ADVIA CENTAUR PSA ASSAY (P950021/S013)Siemens Healthcare Diagnostics2012-10-15
ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S009)Siemens Healthcare Diagnostics2012-10-15
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S017)Siemens Healthcare Diagnostics2012-03-22
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S022)Siemens Healthcare Diagnostics2012-03-16
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S018)Siemens Healthcare Diagnostics2012-03-16
ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S008)Siemens Healthcare Diagnostics2012-02-03
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S021)Siemens Healthcare Diagnostics2011-12-15
DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S016)Siemens Healthcare Diagnostics2011-12-15
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM (P000021/S020)Siemens Healthcare Diagnostics2011-11-23
DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM (P020027/S015)Siemens Healthcare Diagnostics2011-11-23
ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL (P090024)Siemens Healthcare Diagnostics2011-10-11
ADVIA CENTAUR ANTI-HBS ASSAY (P030029/S012)Siemens Healthcare Diagnostics2011-03-14
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P000021/S018)Siemens Healthcare Diagnostics2011-03-11
DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S013)Siemens Healthcare Diagnostics2011-03-11
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S019)Siemens Healthcare Diagnostics2010-12-13
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S014)Siemens Healthcare Diagnostics2010-12-13
ADVIA ANTI-HBS ASSAY (P030029/S011)Siemens Healthcare Diagnostics2010-10-18
DIMENSIONS TPSA FLE REAGENT CARTRIDGE (P000021/S017)Siemens Healthcare Diagnostics2010-09-02
DIMENSIONS FPSA FLEX REAGENT CARTRIDGE (P020027/S012)Siemens Healthcare Diagnostics2010-09-02
ADVIA CENTAUR ANTI-HBS (AHBS) (P030029/S009)Siemens Healthcare Diagnostics2010-09-01
ADVIA CENTAUR PSA ASSAY (P950021/S012)Siemens Healthcare Diagnostics2010-08-30
ADVIA CENTAUR CPSA ASSAY (P990055/S013)Siemens Healthcare Diagnostics2010-08-30
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S015)Siemens Healthcare Diagnostics2010-05-27
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S010)Siemens Healthcare Diagnostics2010-05-27
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S013)Siemens Healthcare Diagnostics2010-05-19
FPSA FLEX REAGENT CARTRIDGE (P020027/S009)Siemens Healthcare Diagnostics2010-05-17
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S011)Siemens Healthcare Diagnostics2010-04-26
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S016)Siemens Healthcare Diagnostics2010-04-26
ADVIA CENTAUR HBSAG ASSAY (P030049/S008)Siemens Healthcare Diagnostics2010-04-20
ADVIA CENTAUR HBC IGM ASSAY (P030040/S007)Siemens Healthcare Diagnostics2010-03-16
ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S007)Siemens Healthcare Diagnostics2010-01-29
ADVIA CENTAUR COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY (P990055/S010)Siemens Healthcare Diagnostics2009-12-03
ADVIA CENTAUR PSA & ADVIA CENTAUR CP PSA IMMUNOASSAY (P950021/S009)Siemens Healthcare Diagnostics2009-12-03
ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040/S002)Siemens Healthcare Diagnostics2009-10-20
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS (P040004/S002)Siemens Healthcare Diagnostics2009-10-20
ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS (P030049/S002)Siemens Healthcare Diagnostics2009-09-25
ADVIA CENTAUR AHBS ASSAY (P030029/S008)Siemens Healthcare Diagnostics2009-09-15
ADVIA CENTAUR ANTI-HBC IGM (P030040/S005)Siemens Healthcare Diagnostics2009-08-20
ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV (P030056/S005)Siemens Healthcare Diagnostics2009-08-20
ADVIA CENTAUR HBSAG (HBS) AND HBSAG CONFIRMATORY (P030049/S005)Siemens Healthcare Diagnostics2009-08-20
ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HBCT (P040004/S005)Siemens Healthcare Diagnostics2009-08-20
ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI - HBS (P030029/S006)Siemens Healthcare Diagnostics2009-08-20
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV (P030056/S006)Siemens Healthcare Diagnostics2009-08-19
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBCT (P040004/S006)Siemens Healthcare Diagnostics2009-08-19
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS (P030029/S007)Siemens Healthcare Diagnostics2009-08-19
ADVIA CENTAUR XP SOFTWARE V6.0 HBSAG & HBSAG CONFIRMATORY (P030049/S007)Siemens Healthcare Diagnostics2009-08-19
ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBC IGM (P030040/S006)Siemens Healthcare Diagnostics2009-08-19
ADVIA CENTAUR HCV ON CENTAUR CP (P030056/S002)Siemens Healthcare Diagnostics2009-08-13
ADVIA CENTAUR AHBS (P030029/S003)Siemens Healthcare Diagnostics2009-07-31
ADVIA CENTAUR XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE) (P950021/S011)Siemens Healthcare Diagnostics2009-06-10
ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE) (P990055/S012)Siemens Healthcare Diagnostics2009-06-10
ADVIA CENTAUR ANTI-HBS (AHBS) (P030029/S004)Siemens Healthcare Diagnostics2009-06-10
DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE (P000021/S014)Siemens Healthcare Diagnostics2009-06-04
ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY (P030049/S006)Siemens Healthcare Diagnostics2009-05-27
ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL (P030049/S004)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/TOTAL QUALITY CONTROL MATERIALS (P040004/S004)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS (P030056/S004)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS & CONTROL MATERIAL (P030029/S005)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS (P030040/S004)Siemens Healthcare Diagnostics2009-04-09
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Every clearance here is in the API, with alerts when new ones post.