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Beckman Coulter, Inc.

183 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
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
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
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
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
ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026)Beckman Coulter, Inc.2012-06-14
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
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
ACCESS IMMUNOASSAY SYSTEMS (P980041/S013)Beckman Coulter, Inc.2011-07-01
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
ACCESS HYBRITECH FREE PSA ASSAY (P970038/S012)Beckman Coulter, Inc.2008-08-13
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S012)Beckman Coulter, Inc.2008-07-28
ACCESS HYBRITECH PSA WHO STANDARDIZATION (P850048/S021)Beckman Coulter, Inc.2008-05-09
ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S011)Beckman Coulter, Inc.2008-03-26
ACCESS HYBRITECT FREE PSA (P970038/S011)Beckman Coulter, Inc.2008-03-06
ACCESS HYBRITECH PSA IMMUNOASSAY (P850048/S023)Beckman Coulter, Inc.2008-02-26
IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S010)Beckman Coulter, Inc.2007-11-27
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S009)Beckman Coulter, Inc.2007-09-19
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S022)Beckman Coulter, Inc.2007-09-18
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S009)Beckman Coulter, Inc.2007-09-12
ACCESS HYBRITECH FREE PSA (P970038/S010)Beckman Coulter, Inc.2007-06-13
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S020)Beckman Coulter, Inc.2006-05-18
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS (P970038/S008)Beckman Coulter, Inc.2006-05-18
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S008)Beckman Coulter, Inc.2006-05-16
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S007)Beckman Coulter, Inc.2006-01-30
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S006)Beckman Coulter, Inc.2004-08-04
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S005)Beckman Coulter, Inc.2004-07-15
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S004)Beckman Coulter, Inc.2004-01-20
ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS (P850048/S019)Beckman Coulter, Inc.2003-03-03
ACCESS HYBRITECH FREE PSA ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (P970038/S007)Beckman Coulter, Inc.2003-02-28
ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM (P980041/S003)Beckman Coulter, Inc.2003-01-29
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
ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS (P980041/S001)Beckman Coulter, Inc.2002-10-01
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
TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY (P850048/S015)Beckman Coulter, Inc.1999-08-03
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
TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY (P970038/S001)Beckman Coulter, Inc.1998-09-24
TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY (P970038)Beckman Coulter, Inc.1998-03-10
TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY (P850048/S012)Beckman Coulter, Inc.1996-05-03
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY (P850048/S011)Beckman Coulter, Inc.1995-11-06
HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC (P850048/S009)Beckman Coulter, Inc.1994-08-25
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
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S006)Beckman Coulter, Inc.1990-11-05
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S005)Beckman Coulter, Inc.1990-07-10
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S003)Beckman Coulter, Inc.1989-08-21
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S004)Beckman Coulter, Inc.1989-08-10
TANDEM(R)-E AFP (P840035/S007)Beckman Coulter, Inc.1988-06-03
TANDEM(R)-E AFP (P840035/S003)Beckman Coulter, Inc.1988-04-29
TANDEM(R)-E AFP (P840035/S006)Beckman Coulter, Inc.1987-08-05
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S001)Beckman Coulter, Inc.1987-07-23
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S002)Beckman Coulter, Inc.1987-07-10
TANDEM(R)-E AFP (P840035/S004)Beckman Coulter, Inc.1986-09-02
ENCORE AFP (P840035/S002)Beckman Coulter, Inc.1986-04-08
TANDEM(R)-E AFP (P840035/S001)Beckman Coulter, Inc.1986-03-06
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048)Beckman Coulter, Inc.1986-02-25
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