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Siemens Healthcare Diagnostics

252 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ADVIA CENTAUR PSA ASSAY (P950021/S010)Siemens Healthcare Diagnostics2009-03-06
ADVIA CENTAUR PSA & CPSA ASSAYS (P990055/S011)Siemens Healthcare Diagnostics2009-03-06
ADVIA CENTAUR HBCIGM (P030040/S003)Siemens Healthcare Diagnostics2009-03-04
ADVIA CENTAUR HCV (P030056/S003)Siemens Healthcare Diagnostics2009-03-04
ADVIA CENTAUR HBSAG (P030049/S003)Siemens Healthcare Diagnostics2009-03-04
ADVIA CENTAUR HBCT (P040004/S003)Siemens Healthcare Diagnostics2009-03-04
DIMENSION FPSA FLEX REAGENT (P020027/S008)Siemens Healthcare Diagnostics2008-03-14
TPSA FLEX REAGENT (P000021/S012)Siemens Healthcare Diagnostics2008-03-14
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S011)Siemens Healthcare Diagnostics2008-03-13
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S007)Siemens Healthcare Diagnostics2008-03-13
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S006)Siemens Healthcare Diagnostics2007-09-14
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S010)Siemens Healthcare Diagnostics2007-09-14
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS (P030029/S001)Siemens Healthcare Diagnostics2007-08-02
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S009)Siemens Healthcare Diagnostics2007-01-04
DIMENSION FPSA FLEX REAGENT CATRIDGE (P020027/S005)Siemens Healthcare Diagnostics2007-01-04
ADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA) (P990055/S009)Siemens Healthcare Diagnostics2006-11-06
ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSAY (CPSA) (P950021/S008)Siemens Healthcare Diagnostics2006-11-06
BAYER ADVIA IMS COMPLEXED PSA ASSAY (P990055/S008)Siemens Healthcare Diagnostics2005-10-07
ADVIA CENTAUR CP PSA ASSAY (P950021/S007)Siemens Healthcare Diagnostics2005-10-07
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S004)Siemens Healthcare Diagnostics2005-07-13
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S008)Siemens Healthcare Diagnostics2005-07-11
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S006)Siemens Healthcare Diagnostics2005-06-02
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S003)Siemens Healthcare Diagnostics2005-06-02
ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL (P030049)Siemens Healthcare Diagnostics2005-05-26
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S002)Siemens Healthcare Diagnostics2005-02-11
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S005)Siemens Healthcare Diagnostics2005-02-11
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS (P040004)Siemens Healthcare Diagnostics2004-12-22
ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS (P030056)Siemens Healthcare Diagnostics2004-12-22
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S004)Siemens Healthcare Diagnostics2004-12-02
ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040)Siemens Healthcare Diagnostics2004-08-06
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS (P030029)Siemens Healthcare Diagnostics2004-05-14
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S003)Siemens Healthcare Diagnostics2003-12-30
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S001)Siemens Healthcare Diagnostics2003-10-10
BAYER ADVIA IMS PSA ASSAY (P950021/S006)Siemens Healthcare Diagnostics2003-09-02
BAYER ADVIA IMS CPSA ASSAY (P990055/S007)Siemens Healthcare Diagnostics2003-09-02
ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS (P990055/S006)Siemens Healthcare Diagnostics2003-05-09
DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS (P020027)Siemens Healthcare Diagnostics2003-01-24
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S002)Siemens Healthcare Diagnostics2002-09-10
IMMUNO 1 COMPLEXED PSA ASSAY (P990055/S005)Siemens Healthcare Diagnostics2002-09-04
ACS:180 & ADVIA CENTAUR CPSA IMMUNOASSAYS (P990055/S004)Siemens Healthcare Diagnostics2002-07-19
COMPLEXED PSA MICROTITER ELISA (P990055/S002)Siemens Healthcare Diagnostics2002-03-19
TOTAL PSA MICROTITER ELISA (P950021/S004)Siemens Healthcare Diagnostics2002-03-19
TOTAL PSA MICROTITER ELISA (P950021/S005)Siemens Healthcare Diagnostics2002-03-13
COMPLEXED PSA MICROTITER ELISA (P990055/S003)Siemens Healthcare Diagnostics2002-03-13
BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS (P990055/S001)Siemens Healthcare Diagnostics2001-12-07
ACS:180 AND ADVIA CENTAUR PSA IMMUNOASSAYS (P950021/S003)Siemens Healthcare Diagnostics2001-08-06
DIMENSION PSA FLEX REAGENT CARTRIDGE (P000021/S001)Siemens Healthcare Diagnostics2001-07-31
DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE (P000021)Siemens Healthcare Diagnostics2001-07-05
ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY (P950021/S002)Siemens Healthcare Diagnostics2000-12-22
BAYER IMMUNO 1 COMPLEXED PSA ASSAY (P990055)Siemens Healthcare Diagnostics2000-09-08
BAYER IMMUNO 1 SYSTEM (P950021/S001)Siemens Healthcare Diagnostics1999-06-25
ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY (P950021)Siemens Healthcare Diagnostics1995-12-22
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Every clearance here is in the API, with alerts when new ones post.