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Beckman Coulter, Inc.

183 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Access AFP (on DxI 9000 Analyzer) (P980041/S051)Beckman Coulter, Inc.2025-11-03
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015)Beckman Coulter, Inc.2025-10-17
Access Hybritech p2PSA (P090026/S032)Beckman Coulter, Inc.2025-06-16
Access Hybritech free PSA (P970038/S046)Beckman Coulter, Inc.2025-05-15
Access Hybritech PSA (P850048/S060)Beckman Coulter, Inc.2024-09-04
Access Hybritech PSA reagent pack (P850048/S059)Beckman Coulter, Inc.2023-05-25
Access AFP Reagents on the Access Immunoassay Systems (P980041/S050)Beckman Coulter, Inc.2022-12-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057)Beckman Coulter, Inc.2022-12-16
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S031)Beckman Coulter, Inc.2022-12-16
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S045)Beckman Coulter, Inc.2022-12-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S058)Beckman Coulter, Inc.2022-03-03
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S030)Beckman Coulter, Inc.2020-12-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S056)Beckman Coulter, Inc.2020-12-16
Access AFP Reagents on the Access Immunoassay Systems (P980041/S049)Beckman Coulter, Inc.2020-12-16
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S044)Beckman Coulter, Inc.2020-12-16
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S029)Beckman Coulter, Inc.2020-10-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S055)Beckman Coulter, Inc.2020-10-16
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S043)Beckman Coulter, Inc.2020-10-16
Access AFP Reagents on the Access Immunoassay System (P980041/S048)Beckman Coulter, Inc.2020-10-16
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S028)Beckman Coulter, Inc.2020-10-07
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S042)Beckman Coulter, Inc.2020-10-07
Access AFP Reagents on the Access Immunoassay Systems (P980041/S047)Beckman Coulter, Inc.2020-10-07
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S054)Beckman Coulter, Inc.2020-10-07
Acess AFP Reagents on the Access Immunoassay Systems (P980041/S043)Beckman Coulter, Inc.2020-05-28
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S053)Beckman Coulter, Inc.2020-03-17
Access AFP Reagents on the Access Immunoassay Systems (P980041/S046)Beckman Coulter, Inc.2020-03-17
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S041)Beckman Coulter, Inc.2020-03-17
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S027)Beckman Coulter, Inc.2020-03-17
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S052)Beckman Coulter, Inc.2019-08-09
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S026)Beckman Coulter, Inc.2019-08-09
Access AFP Reagents on the Access Immunoassay Systems (P980041/S045)Beckman Coulter, Inc.2019-08-09
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S040)Beckman Coulter, Inc.2019-08-09
Access AFP Reagents on the Access Immunoassay Systems (P980041/S044)Beckman Coulter, Inc.2019-07-31
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S051)Beckman Coulter, Inc.2019-07-31
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S025)Beckman Coulter, Inc.2019-07-31
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S039)Beckman Coulter, Inc.2019-07-31
Access Hybritech p2PSA Reagent Pack (P090026/S023)Beckman Coulter, Inc.2019-01-09
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S037)Beckman Coulter, Inc.2018-12-21
Acess AFP Reagents on the Access Immunoassay Systems (P980041/S041)Beckman Coulter, Inc.2018-12-21
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S022)Beckman Coulter, Inc.2018-12-21
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S049)Beckman Coulter, Inc.2018-12-21
Access AFP Reagents on the Access Immunoassay Systems (P980041/S040)Beckman Coulter, Inc.2018-09-12
Access Hybritech p2PSA Reagents on the Access Immunoassay System (P090026/S021)Beckman Coulter, Inc.2017-10-24
Access AFP Immunoassay (P980041/S039)Beckman Coulter, Inc.2017-10-24
Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems (P970038/S036)Beckman Coulter, Inc.2017-10-24
Access Hybritech PSA Assay (P850048/S048)Beckman Coulter, Inc.2017-10-24
Access Hybritech PSA Reagents on the Access Immunoassy Systems (P850048/S046)Beckman Coulter, Inc.2017-07-07
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S019)Beckman Coulter, Inc.2017-07-07
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S034)Beckman Coulter, Inc.2017-07-07
Access AFP Reagents on the Access Immunoassy Systems (P980041/S037)Beckman Coulter, Inc.2017-07-07
Access AFP Reagents on the Access Immunoassay Systems (P980041/S036)Beckman Coulter, Inc.2017-06-16
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S033)Beckman Coulter, Inc.2017-06-16
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S018)Beckman Coulter, Inc.2017-06-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S045)Beckman Coulter, Inc.2017-06-16
ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S017)Beckman Coulter, Inc.2017-02-21
ACCESS FREE PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER (P970038/S032)Beckman Coulter, Inc.2017-02-14
ACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER (P090026/S016)Beckman Coulter, Inc.2017-02-14
ACCESS PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER (P850048/S044)Beckman Coulter, Inc.2017-02-14
ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S035)Beckman Coulter, Inc.2017-02-14
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S034)Beckman Coulter, Inc.2016-11-18
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S043)Beckman Coulter, Inc.2016-11-09
ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P850048/S042)Beckman Coulter, Inc.2016-08-26
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S033)Beckman Coulter, Inc.2015-07-08
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S041)Beckman Coulter, Inc.2015-06-23
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S032)Beckman Coulter, Inc.2015-06-23
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S015)Beckman Coulter, Inc.2015-06-23
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S031)Beckman Coulter, Inc.2015-06-23
ACCESS HYBRITECH FREE PSA REAGENT ASSAY (P970038/S030)Beckman Coulter, Inc.2015-06-09
ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT (P970038/S029)Beckman Coulter, Inc.2015-03-20
ACCESS HYBRITECH PSA ASSAY (P850048/S040)Beckman Coulter, Inc.2015-03-20
ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM (P090026/S014)Beckman Coulter, Inc.2015-03-20
ACCESS AFP IMMUNOASSAY SYSTEM (P980041/S030)Beckman Coulter, Inc.2015-03-20
ACCESS HYBRITECH PSA ASSAY (P850048/S038)Beckman Coulter, Inc.2014-12-23
ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT (P970038/S027)Beckman Coulter, Inc.2014-12-23
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S012)Beckman Coulter, Inc.2014-12-23
ACCESS AFP IMMUNOASSAY SYSTEM (P980041/S028)Beckman Coulter, Inc.2014-12-23
ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S031)Beckman Coulter, Inc.2014-12-08
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S029)Beckman Coulter, Inc.2014-10-24
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S013)Beckman Coulter, Inc.2014-10-24
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S028)Beckman Coulter, Inc.2014-10-24
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S039)Beckman Coulter, Inc.2014-10-24
ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM (P090026/S011)Beckman Coulter, Inc.2014-07-07
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S027)Beckman Coulter, Inc.2014-05-01
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S026)Beckman Coulter, Inc.2014-05-01
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S010)Beckman Coulter, Inc.2014-05-01
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S037)Beckman Coulter, Inc.2014-05-01
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S024)Beckman Coulter, Inc.2013-10-17
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S025)Beckman Coulter, Inc.2013-10-17
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S035)Beckman Coulter, Inc.2013-10-17
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S025)Beckman Coulter, Inc.2013-10-17
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S008)Beckman Coulter, Inc.2013-10-17
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S009)Beckman Coulter, Inc.2013-10-17
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S026)Beckman Coulter, Inc.2013-10-17
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S036)Beckman Coulter, Inc.2013-10-17
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
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
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