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Immunology

891 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P970038/S015)Beckman Coulter, Inc.2012-02-17
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P850048/S026)Beckman Coulter, Inc.2012-02-17
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S016)Beckman Coulter, Inc.2012-02-17
IMMUNOASAY, PSA (P910065/S008)Tosoh Bioscience, Inc.2012-02-13
VIDAS TOTAL PSA (TPSA) (P040008/S002)bioMerieux, Inc.2012-02-08
VIDAS FREE PSA (FPSA) ASSAY (P080008/S001)bioMerieux, Inc.2012-02-08
ALERE NMP22 URINE COLLECTION KIT (P940035/S007)Abbott Diagnostics Scarborough, Inc.2012-01-20
AXSYM TOTAL PSA (LN 3C19) (P910007/S032)Abbott Laboratories2011-12-22
AXSYM AFP (LN 7A48) (P820060/S030)Abbott Laboratories2011-12-22
AXSYM FREE PSA (LN 3C20) (P980007/S023)Abbott Laboratories2011-12-22
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S015)Roche Diagnostics Corp.2011-12-21
ARCHITECT TOTAL PSA (P910007/S033)Abbott Laboratories2011-12-21
ELECSYS FREE PSA IMMUNOASSAY (P000027/S013)Roche Diagnostics Corp.2011-12-21
ARCHITECT FREE PSA (P980007/S024)Abbott Laboratories2011-12-21
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
NMP22 BLADDERCHEK TEST KIT (P940035/S006)Abbott Diagnostics Scarborough, Inc.2011-11-15
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S013)Roche Diagnostics Corp.2011-09-23
ELECSYS FREE PSA IMMUNOASSAY (P000027/S011)Roche Diagnostics Corp.2011-09-23
AXSYM TOTAL PSA & ARCHITECT TOTAL PSA (P910007/S031)Abbott Laboratories2011-09-13
AXSYM FREE PSA & ARCHITECT FREE PSA (P980007/S022)Abbott Laboratories2011-09-13
IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP (P010007/S007)Siemens Healthcare Diagnostics, Inc.2011-09-12
IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA (P930027/S013)Siemens Healthcare Diagnostics, Inc.2011-09-12
IMMULITE/IMMULITE 1000 FREE PSA AND IMMULITE 2000 FREE PSA (P060005/S006)Siemens Medical Solutions Diagnostics Limited2011-09-12
PSA IMMULITE ASSAY (P930027/S012)Siemens Healthcare Diagnostics, Inc.2011-09-07
AFP IMMULITE ASSAY (P010007/S006)Siemens Healthcare Diagnostics, Inc.2011-09-07
FPSA IMMULITE ASSAY (P060005/S005)Siemens Medical Solutions Diagnostics Limited2011-09-07
ARCHITECT TOTAL PSA (P910007/S021)Abbott Laboratories2011-07-26
ARCHITECT FREE PSA (P980007/S013)Abbott Laboratories2011-07-26
ARCHITECT FREE PSA (P980007/S020)Abbott Laboratories2011-07-22
ARCHITECT TOTAL PSA (P910007/S029)Abbott Laboratories2011-07-22
ACCESS IMMUNOASSAY SYSTEMS (P980041/S013)Beckman Coulter, Inc.2011-07-01
AUTODELFIA / DELFIA XPRESS HAFP TEST SYSTEM (P970037/S006)Revvity, Inc.2011-06-24
ARCHITECT FREE PSA (P980007/S021)Abbott Laboratories2011-06-24
ARCHITECT TOTAL PSA (P910007/S030)Abbott Laboratories2011-06-24
ARCHITECT FREE PSA (P980007/S017)Abbott Laboratories2011-06-22
ARCHITECT TOTAL PSA (P910007/S026)Abbott Laboratories2011-06-22
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S011)Roche Diagnostics Corp.2011-06-20
ELECSYS FREE PSA IMMUNOASSAY (P000027/S009)Roche Diagnostics Corp.2011-06-20
AXSYM AFP (P820060/S027)Abbott Laboratories2011-06-10
AXSYM FREE PSA (P980007/S016)Abbott Laboratories2011-06-10
AXSYM TOTAL PSA (P910007/S025)Abbott Laboratories2011-06-10
ARCHITECT TOTAL PSA (LN 6C06) (P910007/S023)Abbott Laboratories2011-06-08
ELECSYS FREE PSA IMMUNOASSAY (P000027/S010)Roche Diagnostics Corp.2011-05-24
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S012)Roche Diagnostics Corp.2011-05-24
AXSYM AFP (P820060/S026)Abbott Laboratories2011-05-20
AXSYM TOTAL PSA (P910007/S022)Abbott Laboratories2011-05-20
AXSYM FREE PSA (P980007/S014)Abbott Laboratories2011-05-20
ABBOTT AXSYM AFP (P820060/S029)Abbott Laboratories2011-05-12
ARCHITECT FREE PSA (P980007/S019)Abbott Laboratories2011-05-11
ARCHITECT TOTAL PSA (P910007/S028)Abbott Laboratories2011-05-11
IMMULITE/IMMULITE 2000 PSA (P930027/S011)Siemens Healthcare Diagnostics, Inc.2011-04-26
IMMULITE/IMMULITE 2000 AFP (P010007/S005)Siemens Healthcare Diagnostics, Inc.2011-04-26
IMMULITE/IMMULITE 2000 FREE PSA (P060005/S004)Siemens Medical Solutions Diagnostics Limited2011-04-26
AUTODELFIA HAFP KIT (P970037/S005)Revvity, Inc.2011-04-08
ARCHITECT FREE PSA (P980007/S011)Abbott Laboratories2011-03-31
ABBOTT ARCHITECT TOTAL PSA (P910007/S019)Abbott Laboratories2011-03-22
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
ARCHITECT TOTAL PSA (P910007/S027)Abbott Laboratories2011-03-07
ARCHITECT FREE PSA (P980007/S018)Abbott Laboratories2011-03-07
AUTODELFIA/DELFIA XPRESS HAFP (P970037/S004)Revvity, Inc.2011-03-04
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S013)Beckman Coulter, Inc.2011-02-07
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S024)Beckman Coulter, Inc.2011-02-07
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S014)Beckman Coulter, Inc.2011-02-07
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S025)Beckman Coulter, Inc.2011-02-04
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S014)Beckman Coulter, Inc.2011-02-04
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S015)Beckman Coulter, Inc.2011-02-04
ARCHITECT FREE PSA (P980007/S015)Abbott Laboratories2011-01-13
ARCHITECT TOTAL PSA (P910007/S024)Abbott Laboratories2011-01-13
AUTODELFIA XPRESS HAFP TEST SYSTEM (P970037/S003)Revvity, Inc.2011-01-12
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S019)Siemens Healthcare Diagnostics2010-12-13
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S014)Siemens Healthcare Diagnostics2010-12-13
AXSYM AFP (LN 7A48) (P820060/S025)Abbott Laboratories2010-10-20
AXSYM FREE PSA (LN 3C20) (P980007/S012)Abbott Laboratories2010-10-20
AXSYM TOTAL PSA (LN 3C19) (P910007/S020)Abbott Laboratories2010-10-20
DIMENSIONS TPSA FLE REAGENT CARTRIDGE (P000021/S017)Siemens Healthcare Diagnostics2010-09-02
DIMENSIONS FPSA FLEX REAGENT CARTRIDGE (P020027/S012)Siemens Healthcare Diagnostics2010-09-02
ABBOTT ARCHITECT TOTAL PSA ASSAY (P910007/S018)Abbott Laboratories2010-08-31
ARCHITECT FREE PSA ASSAY (P980007/S010)Abbott Laboratories2010-08-31
ADVIA CENTAUR PSA ASSAY (P950021/S012)Siemens Healthcare Diagnostics2010-08-30
ADVIA CENTAUR CPSA ASSAY (P990055/S013)Siemens Healthcare Diagnostics2010-08-30
ELECSYS FREE PSA CALCHECK (P000027/S008)Roche Diagnostics Corp.2010-06-08
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
ABBOTT AFP-EIA (P820060/S024)Abbott Laboratories2010-02-26
SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS (P930027/S008)Siemens Healthcare Diagnostics, Inc.2010-02-25
IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 AFP (P010007/S004)Siemens Healthcare Diagnostics, Inc.2010-01-21
IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA (P060005/S003)Siemens Medical Solutions Diagnostics Limited2010-01-21
IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATION PSA (P930027/S010)Siemens Healthcare Diagnostics, Inc.2010-01-21
ADVIA CENTAUR COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY (P990055/S010)Siemens Healthcare Diagnostics2009-12-03
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S010)Roche Diagnostics Corp.2009-12-03
ADVIA CENTAUR PSA & ADVIA CENTAUR CP PSA IMMUNOASSAY (P950021/S009)Siemens Healthcare Diagnostics2009-12-03
ST AIA-PACK PA (P910065/S007)Tosoh Bioscience, Inc.2009-11-30
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Every clearance here is in the API, with alerts when new ones post.