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Ortho-Clinical Diagnostics, Inc.

167 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S015)Ortho-Clinical Diagnostics, Inc.2009-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S017)Ortho-Clinical Diagnostics, Inc.2009-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S014)Ortho-Clinical Diagnostics, Inc.2009-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR, HBSAG CONFIRMATORY ASSAY (P000044/S018)Ortho-Clinical Diagnostics, Inc.2008-06-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S013)Ortho-Clinical Diagnostics, Inc.2008-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S014)Ortho-Clinical Diagnostics, Inc.2008-03-05
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S017)Ortho-Clinical Diagnostics, Inc.2008-02-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S012)Ortho-Clinical Diagnostics, Inc.2008-02-20
VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI HB-S QUANTITATIVE REAGENT PACK & CALIBRATORS (P000014/S016)Ortho-Clinical Diagnostics, Inc.2008-02-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR (P010021/S011)Ortho-Clinical Diagnostics, Inc.2007-06-21
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S015)Ortho-Clinical Diagnostics, Inc.2007-06-06
VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR (P010021/S010)Ortho-Clinical Diagnostics, Inc.2007-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & CONFIRMATORY KIT (P000044/S016)Ortho-Clinical Diagnostics, Inc.2007-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S013)Ortho-Clinical Diagnostics, Inc.2007-04-06
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT (P000044/S015)Ortho-Clinical Diagnostics, Inc.2007-03-27
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S012)Ortho-Clinical Diagnostics, Inc.2007-03-05
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S011)Ortho-Clinical Diagnostics, Inc.2006-09-12
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT (P000044/S014)Ortho-Clinical Diagnostics, Inc.2006-09-06
VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT (P000044/S013)Ortho-Clinical Diagnostics, Inc.2006-07-14
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & PRODUCTS HBSAG CONFIRMATORY KIT (P000044/S012)Ortho-Clinical Diagnostics, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S010)Ortho-Clinical Diagnostics, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S014)Ortho-Clinical Diagnostics, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR, AND HBSAG CONFIRMATORY KIT (P000044/S011)Ortho-Clinical Diagnostics, Inc.2006-04-03
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S007)Ortho-Clinical Diagnostics, Inc.2006-01-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S008)Ortho-Clinical Diagnostics, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S010)Ortho-Clinical Diagnostics, Inc.2005-12-08
IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S013)Ortho-Clinical Diagnostics, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODICTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S009)Ortho-Clinical Diagnostics, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATORS (P000044/S009)Ortho-Clinical Diagnostics, Inc.2005-11-17
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S008)Ortho-Clinical Diagnostics, Inc.2005-10-21
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS (P000044/S008)Ortho-Clinical Diagnostics, Inc.2005-09-22
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S006)Ortho-Clinical Diagnostics, Inc.2005-08-11
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR/CONFIRMATORY KIT (P000044/S007)Ortho-Clinical Diagnostics, Inc.2005-08-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S007)Ortho-Clinical Diagnostics, Inc.2005-07-18
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S006)Ortho-Clinical Diagnostics, Inc.2005-06-22
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S012)Ortho-Clinical Diagnostics, Inc.2005-05-25
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR (P000044/S006)Ortho-Clinical Diagnostics, Inc.2005-05-05
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S005)Ortho-Clinical Diagnostics, Inc.2005-04-15
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HB REAGENT PACK & CALIBRATORS (P000014/S011)Ortho-Clinical Diagnostics, Inc.2005-03-29
VITROS IMMUNODIAGNOSTIC ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S005)Ortho-Clinical Diagnostics, Inc.2005-02-11
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S004)Ortho-Clinical Diagnostics, Inc.2005-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S003)Ortho-Clinical Diagnostics, Inc.2005-01-04
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR (P000044/S005)Ortho-Clinical Diagnostics, Inc.2004-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK AND CALIBRATOR (P000044/S004)Ortho-Clinical Diagnostics, Inc.2004-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S002)Ortho-Clinical Diagnostics, Inc.2004-11-04
VITROS IMMUNODIAGNOSTIC ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S010)Ortho-Clinical Diagnostics, Inc.2004-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S004)Ortho-Clinical Diagnostics, Inc.2004-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS (P000014/S009)Ortho-Clinical Diagnostics, Inc.2004-09-27
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S003)Ortho-Clinical Diagnostics, Inc.2004-07-30
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS (P010021/S002)Ortho-Clinical Diagnostics, Inc.2004-07-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S008)Ortho-Clinical Diagnostics, Inc.2004-07-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S001)Ortho-Clinical Diagnostics, Inc.2004-06-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S007)Ortho-Clinical Diagnostics, Inc.2004-05-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR (P030026)Ortho-Clinical Diagnostics, Inc.2004-03-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S006)Ortho-Clinical Diagnostics, Inc.2003-07-09
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S001)Ortho-Clinical Diagnostics, Inc.2003-04-30
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK/ CALIBRATOR (P000044/S003)Ortho-Clinical Diagnostics, Inc.2003-03-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS (P000014/S005)Ortho-Clinical Diagnostics, Inc.2003-02-24
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021)Ortho-Clinical Diagnostics, Inc.2001-08-30
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS (P000014/S002)Ortho-Clinical Diagnostics, Inc.2001-08-29
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT (P000044/S002)Ortho-Clinical Diagnostics, Inc.2001-06-18
VITROS IMMUNODIAGNOSTIC PRODUCTS HBS AG REAGENT PACK/CALIBRATOR/CONFIRMATORY KIT (P000044/S001)Ortho-Clinical Diagnostics, Inc.2001-05-24
VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR (P000044)Ortho-Clinical Diagnostics, Inc.2001-04-27
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS (P000014/S004)Ortho-Clinical Diagnostics, Inc.2001-04-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS (P000014/S003)Ortho-Clinical Diagnostics, Inc.2001-04-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS (P000014/S001)Ortho-Clinical Diagnostics, Inc.2001-03-20
VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS (P000014)Ortho-Clinical Diagnostics, Inc.2000-09-29
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