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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 SYSTEMS (P850048/S034)Beckman Coulter, Inc.2013-08-20
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S007)Beckman Coulter, Inc.2013-08-20
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S024)Beckman Coulter, Inc.2013-08-20
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S023)Beckman Coulter, Inc.2013-08-20
ELECSYS ANTI-HBC IGM ASSAY (MODULAR ANALYTICS E170 ANALYZER) (P110025/S010)Roche Diagnostics Corp.2013-08-06
ELECSYS ANTI-HBC IGM ASSAY (COBAS E 601 ANALYZER) (P110022/S011)Roche Diagnostics Corp.2013-08-06
ELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER) (P110031/S010)Roche Diagnostics Corp.2013-08-06
ALERE NMP22 TEST (P940035/S010)Abbott Diagnostics Scarborough, Inc.2013-07-16
ARCHITECT AFP,LN 3P36 (P120008/S003)Abbott Laboratories2013-06-12
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S033)Beckman Coulter, Inc.2013-06-07
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S023)Beckman Coulter, Inc.2013-06-07
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S022)Beckman Coulter, Inc.2013-06-07
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S006)Beckman Coulter, Inc.2013-06-07
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
ELECSYS FREE PSA CALSET (P000027/S017)Roche Diagnostics Corp.2013-04-10
NMP22 BLADDERCHEK TEST (P940035/S009)Abbott Diagnostics Scarborough, Inc.2013-04-02
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S021)Beckman Coulter, Inc.2013-03-26
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P850048/S032)Beckman Coulter, Inc.2013-03-26
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P090026/S005)Beckman Coulter, Inc.2013-03-26
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S022)Beckman Coulter, Inc.2013-03-25
ARCHITECT TOTAL PSA (P910007/S039)Abbott Laboratories2013-03-13
ARCHITECT FREE PSA (P980007/S030)Abbott Laboratories2013-03-13
VIDAS TOTAL PSA (P040008/S006)bioMerieux, Inc.2013-03-13
ARCHITECT AFP (P120008/S001)Abbott Laboratories2013-03-13
VIDAS TOTAL PSA (P040008/S005)bioMerieux, Inc.2013-03-08
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S023)Siemens Healthcare Diagnostics2013-02-22
ACCESS HYBRITECH PSA REAGENTS ON THE IMMUNOASSAY SYSTEMS (P850048/S031)Beckman Coulter, Inc.2013-02-06
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S021)Beckman Coulter, Inc.2013-02-06
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S020)Beckman Coulter, Inc.2013-02-06
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S004)Beckman Coulter, Inc.2013-02-06
VIDAS TOTAL PSA (P040008/S003)bioMerieux, Inc.2013-01-18
VIDAS FREE PSA RT (P080008/S002)bioMerieux, Inc.2013-01-18
VIDAS TOTAL PSA (P040008/S004)bioMerieux, Inc.2013-01-15
ELECSYS TOTAL PSA CALSET (P990056/S019)Roche Diagnostics Corp.2012-12-26
PRECICONTROL ANTI-HBC IGM (COBAS E 411) (P110031/S008)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S002)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S002)Roche Diagnostics Corp.2012-12-20
PRECICONTROL ANTI-HBC IGM (MODULAR ANALYTICS E170) (P110025/S008)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBC IGM ON COBAS E 411 (P110031/S002)Roche Diagnostics Corp.2012-12-20
PRECICONTROL ANTI-HBC IGM (COBAS E 601) (P110022/S009)Roche Diagnostics Corp.2012-12-20
ELECSYS TOTAL PSA (P990056/S016)Roche Diagnostics Corp.2012-12-18
ELECSYS FREE PSA (P000027/S014)Roche Diagnostics Corp.2012-12-18
ARCHITECT FREE PSA AND AXSYM FREE PSA (P980007/S027)Abbott Laboratories2012-12-11
ARCHITECT TOTAL PSA AND AXSYM TOTAL PSA (P910007/S036)Abbott Laboratories2012-12-11
AXSYM AFP (P820060/S031)Abbott Laboratories2012-12-11
ARCHITECT TOTAL PSA (P910007/S038)Abbott Laboratories2012-12-07
ARCHITECT TOTAL PSA (P910007/S037)Abbott Laboratories2012-12-07
ARCHITECT FREE PSA (P980007/S028)Abbott Laboratories2012-12-07
ARCHITECT FREE PSA (P980007/S029)Abbott Laboratories2012-12-07
ABBOTT ARCHITECT AFP ASSAY (P120008)Abbott Laboratories2012-11-28
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S019)Siemens Healthcare Diagnostics2012-11-20
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S024)Siemens Healthcare Diagnostics2012-11-20
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P850048/S028)Beckman Coulter, Inc.2012-11-19
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P090026/S001)Beckman Coulter, Inc.2012-11-19
ACCESS HYBRITECH FREE PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM (P970038/S017)Beckman Coulter, Inc.2012-11-19
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S018)Beckman Coulter, Inc.2012-11-19
IMMULITE PSA ASSAY (P930027/S015)Siemens Healthcare Diagnostics, Inc.2012-11-08
IMMULITE FPSA ASSAY (P060005/S008)Siemens Medical Solutions Diagnostics Limited2012-11-08
IMMULITE AFP ASSAY (P010007/S009)Siemens Healthcare Diagnostics, Inc.2012-11-08
ADVIA CENTAUR CPSA ASSAY (P990055/S014)Siemens Healthcare Diagnostics2012-10-15
ADVIA CENTAUR PSA ASSAY (P950021/S013)Siemens Healthcare Diagnostics2012-10-15
ADVIA CENTAUR AFP ASSAY (P930036/S005)Siemens Healthcare Diagnostics, Inc.2012-10-15
ARCHITECT FREE PSA (P980007/S026)Abbott Laboratories2012-08-29
ARCHITECT TOTAL PSA (P910007/S035)Abbott Laboratories2012-08-29
ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS (P930036/S004)Siemens Healthcare Diagnostics, Inc.2012-08-14
ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S001)Roche Diagnostics Corp.2012-06-18
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S001)Roche Diagnostics Corp.2012-06-18
ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S001)Roche Diagnostics Corp.2012-06-18
AUTODELFIA HAFP TEST SYSTEM (P970037/S008)Revvity, Inc.2012-06-14
ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026)Beckman Coulter, Inc.2012-06-14
AUOTDELFIA HAFP KIT (P970037/S007)Revvity, Inc.2012-04-27
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S016)Beckman Coulter, Inc.2012-04-13
ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S017)Beckman Coulter, Inc.2012-04-13
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S027)Beckman Coulter, Inc.2012-04-13
AFP IMMULITE SUBSTRATE REAGENT (P010007/S008)Siemens Healthcare Diagnostics, Inc.2012-04-05
PSA IMMULITE SUBSTRATE REAGENT (P930027/S014)Siemens Healthcare Diagnostics, Inc.2012-04-05
FPSA IMMULITE SUBSTRATE REAGENT (P060005/S007)Siemens Medical Solutions Diagnostics Limited2012-04-05
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S006)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S006)Roche Diagnostics Corp.2012-03-28
ELECSYS TOTAL PSA (P990056/S017)Roche Diagnostics Corp.2012-03-28
ELECSYS FREE PSA (P000027/S015)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HBC IGM ON COBAS E 411 (P110031/S006)Roche Diagnostics Corp.2012-03-28
ARCHITECT FREE PSA (P980007/S025)Abbott Laboratories2012-03-22
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S017)Siemens Healthcare Diagnostics2012-03-22
ARCHITECT TOTAL PSA (P910007/S034)Abbott Laboratories2012-03-22
ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT (P940035/S008)Abbott Diagnostics Scarborough, Inc.2012-03-21
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S022)Siemens Healthcare Diagnostics2012-03-16
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S018)Siemens Healthcare Diagnostics2012-03-16
ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S003)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S005)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S005)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S005)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S003)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S003)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S004)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S004)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S004)Roche Diagnostics Corp.2012-02-27
ELECSYS TOTAL PSA (TPSA) TEST SYSTEM (P990056/S014)Roche Diagnostics Corp.2012-02-24
ELECSYS FREE PSA (FPSA) TEST SYSTEM (P000027/S012)Roche Diagnostics Corp.2012-02-24
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Every clearance here is in the API, with alerts when new ones post.