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Immunology

891 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
AFP CONTROL PACK (P820060/S017)Abbott Laboratories2003-03-05
ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS (P850048/S019)Beckman Coulter, Inc.2003-03-03
IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA (P930027/S005)Siemens Healthcare Diagnostics, Inc.2003-02-28
ACCESS HYBRITECH FREE PSA ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (P970038/S007)Beckman Coulter, Inc.2003-02-28
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK (P000027/S002)Roche Diagnostics Corp.2003-02-24
IMMULITE AFP AND IMMULITE 2000 AFP (P010007/S001)Siemens Healthcare Diagnostics, Inc.2003-02-24
ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM (P980041/S003)Beckman Coulter, Inc.2003-01-29
DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS (P020027)Siemens Healthcare Diagnostics2003-01-24
ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 SYSTEM (P970038/S006)Beckman Coulter, Inc.2003-01-09
ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM (P850048/S018)Beckman Coulter, Inc.2003-01-09
ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM (P980041/S002)Beckman Coulter, Inc.2002-12-06
ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER (P850048/S017)Beckman Coulter, Inc.2002-11-27
ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER (P970038/S005)Beckman Coulter, Inc.2002-11-27
AUTODELFIA HAFP TEST KIT (P970037/S001)Revvity, Inc.2002-11-27
ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS (P980041/S001)Beckman Coulter, Inc.2002-10-01
ABBOTT AXSYM AFP (P820060/S015)Abbott Laboratories2002-09-12
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S002)Siemens Healthcare Diagnostics2002-09-10
AIA-PACK PA (P910065/S003)Tosoh Bioscience, Inc.2002-09-09
ABBOTT IMX AFP ASSAY (P820060/S014)Abbott Laboratories2002-09-05
IMX AND AXSYM PSA (P910007/S008)Abbott Laboratories2002-09-05
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
ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK (P000027/S001)Roche Diagnostics Corp.2002-04-29
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
ACS:180/ADVIA CENTAUR AFP IMMUNOASSAY (P930036/S002)Siemens Healthcare Diagnostics, Inc.2002-02-12
ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET (P990056/S001)Roche Diagnostics Corp.2002-02-08
BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS (P990055/S001)Siemens Healthcare Diagnostics2001-12-07
IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP (P010007)Siemens Healthcare Diagnostics, Inc.2001-11-09
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
IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000 (P930027/S004)Siemens Healthcare Diagnostics, Inc.2001-06-19
ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY (P950021/S002)Siemens Healthcare Diagnostics2000-12-22
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027)Roche Diagnostics Corp.2000-12-12
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056)Roche Diagnostics Corp.2000-11-22
BAYER IMMUNO 1 COMPLEXED PSA ASSAY (P990055)Siemens Healthcare Diagnostics2000-09-08
AIA PACK PA (P910065/S002)Tosoh Bioscience, Inc.2000-03-03
ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT (P970038/S004)Beckman Coulter, Inc.2000-02-24
ACCESS(R) HYBRITECH PSA ASSAY (P850048/S016)Beckman Coulter, Inc.2000-02-24
MATRITECH NMP22 TEST KIT (P940035/S002)Abbott Diagnostics Scarborough, Inc.2000-01-18
ST AIA-PACK PA (P910065/S001)Tosoh Bioscience, Inc.1999-09-10
TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY (P850048/S015)Beckman Coulter, Inc.1999-08-03
BAYER IMMUNO 1 SYSTEM (P950021/S001)Siemens Healthcare Diagnostics1999-06-25
TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY (P970038/S002)Beckman Coulter, Inc.1999-06-16
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S013)Beckman Coulter, Inc.1999-06-16
TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY (P970038/S003)Beckman Coulter, Inc.1999-06-16
TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY (P850048/S014)Beckman Coulter, Inc.1999-06-16
ACCESS AFP IMMUNOASSAY SYSTEM (P980041)Beckman Coulter, Inc.1999-02-08
CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002)Bayer Healthcare, LLC1998-12-08
CIBA CORNING ACS PSA IMMUNOASSAY (P920030)Bayer Healthcare, LLC1998-12-08
TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY (P970038/S001)Beckman Coulter, Inc.1998-09-24
ACS: CENTAUR AFP IMMUNOASSAY (P930036/S001)Siemens Healthcare Diagnostics, Inc.1998-07-15
IMMULITE PSA CATALOG # LKPS1,5) (P930027/S003)Siemens Healthcare Diagnostics, Inc.1998-05-08
AUTODELFIA HAFP TEST KIT (P970037)Revvity, Inc.1998-03-31
TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY (P970038)Beckman Coulter, Inc.1998-03-10
ABBOTT AXSYM AFP (P820060/S012)Abbott Laboratories1997-10-29
ABBOTT IMX PSA (P910007/S004)Abbott Laboratories1997-08-07
ABBOTT AXSYM AFP (P820060/S011)Abbott Laboratories1997-05-16
MATRITECH NMP22(TM) TEST KIT (P940035/S001)Abbott Diagnostics Scarborough, Inc.1997-03-19
ABBOTT AXSYM AFP (LIST 7A48) (P820060/S010)Abbott Laboratories1996-12-02
QUANTITOPE 125I AFP KIT AND CONTROL SERUM (P800025/S005)Bio-Rad Laboratories, Inc.1996-10-02
CELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT (P880040/S003)Pierce Biotechnology, Inc.1996-08-07
IMMULITE(R) THIRD GENERATION PSA (P930027/S001)Siemens Healthcare Diagnostics, Inc.1996-07-11
NMP22 BladderChek Test (P940035)Abbott Diagnostics Scarborough, Inc.1996-07-02
TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY (P850048/S012)Beckman Coulter, Inc.1996-05-03
TRUQUANT(R) BR(TM) RIA (P950011)Biomira, Inc.1996-03-29
TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY (P840019/S012)Hybritech, Inc.1996-03-07
OPUS(R) CEA TEST SYSTEM (P920021/S001)Behring Diagnostics, Inc.1996-02-23
ABBOTT AXSYM AFP (LIST 7A48) (P820060/S009)Abbott Laboratories1995-12-26
ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY (P950021)Siemens Healthcare Diagnostics1995-12-22
CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001)Bayer Healthcare, LLC1995-12-13
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY (P850048/S011)Beckman Coulter, Inc.1995-11-06
ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS (P930036)Siemens Healthcare Diagnostics, Inc.1995-09-29
IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS (P930027)Siemens Healthcare Diagnostics, Inc.1995-09-15
ABBOTT CEA-RIA MONOCLONAL (P830066/S012)Abbott Laboratories1995-07-12
ABBOTT AXSYM PSA (LIST 7A49) (P910007/S002)Abbott Laboratories1995-03-29
ABBOTT AXSYM AFP (LIST 7A48) (P820060/S008)Abbott Laboratories1995-03-27
ABBOTT AXSYM CEA (LIST 7A47) (P830066/S011)Abbott Laboratories1995-03-27
CA 125 ANTIBODY RIA (P850009/S007)Centocor, Inc.1994-12-21
ABBOTT IMX PSA (P910007/S003)Abbott Laboratories1994-10-17
ABBOTT IMX(R) PSA* (P910007/S001)Abbott Laboratories1994-09-13
HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC (P850048/S009)Beckman Coulter, Inc.1994-08-25
CA 125 ANTIBODY RIA (P850009/S006)Centocor, Inc.1994-03-23
STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY (P840019/S010)Hybritech, Inc.1994-03-17
TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY (P840019/S011)Hybritech, Inc.1994-01-13
ENZYMUN TEST{R} CEA (P860058/S001)Boehringer Mannheim Corp.1993-07-29
CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S003)Incstar Corp.1993-07-23
AIA-PACK PSA (P910065)Tosoh Bioscience, Inc.1993-07-07
ABBOTT IMX AFP ADDITIONAL PURIFICATION STEP (P820060/S006)Abbott Laboratories1993-07-01
ABBOTT AFP-EIA LABELING CHANGE (P820060/S007)Abbott Laboratories1993-05-13
ABBOTT IMX-CEA (LIST 3A33) (P830066/S009)Abbott Laboratories1992-07-17
CA 125 ANTIBODY RIA (P850009/S005)Centocor, Inc.1992-07-15
HYBRITECH(R) STRATUS(R) PSA ASSAY FLOUROMETRIC (P850048/S007)Beckman Coulter, Inc.1992-05-21
HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC (P850048/S008)Beckman Coulter, Inc.1992-03-24
AXSYM TOTAL PSA & ARCHITECT TOTAL PSA (P910007)Abbott Laboratories1991-09-25
ENZYMUN-TEST{R} AFP (P860044/S003)Boehringer Mannheim Corp.1991-09-03
ENZYMUN-TEST{R} AFP (P860044/S002)Boehringer Mannheim Corp.1991-07-19
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