Atlas FDA

Ortho-Clinical Diagnostics

51 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017)Ortho-Clinical Diagnostics2023-01-24
VITROS Anti-HBe (P100001/S016)Ortho-Clinical Diagnostics2019-06-19
VITROS Anti-HBc (P030024/S029)Ortho-Clinical Diagnostics2019-06-19
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027)Ortho-Clinical Diagnostics2018-10-16
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S012)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S014)Ortho-Clinical Diagnostics2018-07-02
Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S013)Ortho-Clinical Diagnostics2018-02-16
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S011)Ortho-Clinical Diagnostics2017-09-15
VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS (P100001/S010)Ortho-Clinical Diagnostics2017-09-12
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S024)Ortho-Clinical Diagnostics2017-09-01
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR (P100001/S009)Ortho-Clinical Diagnostics2016-10-10
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S023)Ortho-Clinical Diagnostics2015-09-08
VITROS ANTI-HBE ASSAY (P100001/S008)Ortho-Clinical Diagnostics2015-09-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S022)Ortho-Clinical Diagnostics2015-07-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S007)Ortho-Clinical Diagnostics2015-07-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S006)Ortho-Clinical Diagnostics2013-10-17
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S021)Ortho-Clinical Diagnostics2013-09-06
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE (P100001/S005)Ortho-Clinical Diagnostics2012-12-21
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR (P100001/S004)Ortho-Clinical Diagnostics2012-11-19
VITROS ANTI-HBE (P100001/S003)Ortho-Clinical Diagnostics2012-11-13
VITROS ANTI-HBC (P030024/S020)Ortho-Clinical Diagnostics2012-11-13
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S002)Ortho-Clinical Diagnostics2012-10-17
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S019)Ortho-Clinical Diagnostics2012-05-24
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S001)Ortho-Clinical Diagnostics2012-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S018)Ortho-Clinical Diagnostics2012-02-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY (P030024/S017)Ortho-Clinical Diagnostics2011-11-10
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S016)Ortho-Clinical Diagnostics2011-09-27
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS (P100001)Ortho-Clinical Diagnostics2011-07-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S015)Ortho-Clinical Diagnostics2011-05-11
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S014)Ortho-Clinical Diagnostics2011-02-28
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S013)Ortho-Clinical Diagnostics2010-11-16
ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S012)Ortho-Clinical Diagnostics2010-07-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S010)Ortho-Clinical Diagnostics2009-09-11
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS (P030024/S011)Ortho-Clinical Diagnostics2009-03-19
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S009)Ortho-Clinical Diagnostics2009-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS (P030024/S008)Ortho-Clinical Diagnostics2008-02-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S007)Ortho-Clinical Diagnostics2008-02-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S006)Ortho-Clinical Diagnostics2007-06-06
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S005)Ortho-Clinical Diagnostics2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S004)Ortho-Clinical Diagnostics2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S003)Ortho-Clinical Diagnostics2005-05-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S002)Ortho-Clinical Diagnostics2004-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S001)Ortho-Clinical Diagnostics2004-04-02
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR (P030024)Ortho-Clinical Diagnostics2004-03-04
AMERSHAM AFP (P780006/S003)Ortho Clinical Diagnostics1989-09-26
AMERSHAM AFP (P780006/S002)Ortho Clinical Diagnostics1986-03-17
AMERSHAM AFP (P780006)Ortho Clinical Diagnostics1984-06-07

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Every clearance here is in the API, with alerts when new ones post.