FDA 510(k) Applications Submitted by ORTHO-CLINICAL DIAGNOSTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K190490 02/28/2019 VITROS XT Chemistry Products TRIG-CHOL Slides Ortho-Clinical Diagnostics, Inc.
K072732 09/26/2007 ORTHO T. CRUZI ELISA TEST SYSTEM Ortho-Clinical Diagnostics, Inc.
K011250 04/24/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS Ortho-Clinical Diagnostics, Inc.
K031031 04/01/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc.
K973331 09/04/1997 VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) Ortho-Clinical Diagnostics, Inc.
K990016 01/04/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS Ortho-Clinical Diagnostics, Inc.
K990026 01/05/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K990061 01/08/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K990531 02/19/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS Ortho-Clinical Diagnostics, Inc.
K990783 03/09/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K990943 03/22/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK Ortho-Clinical Diagnostics, Inc.
K990984 03/24/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K983031 08/31/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY Ortho-Clinical Diagnostics, Inc.
K983513 10/07/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K983507 10/07/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY Ortho-Clinical Diagnostics, Inc.
K983674 10/20/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS Ortho-Clinical Diagnostics, Inc.
K983690 10/21/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK Ortho-Clinical Diagnostics, Inc.
K983875 11/02/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK Ortho-Clinical Diagnostics, Inc.
K983990 11/09/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY Ortho-Clinical Diagnostics, Inc.
K984011 11/10/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K984166 11/20/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 Ortho-Clinical Diagnostics, Inc.
K984289 12/01/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK Ortho-Clinical Diagnostics, Inc.
K984321 12/03/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS Ortho-Clinical Diagnostics, Inc.
K041799 07/02/2004 VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS Ortho-Clinical Diagnostics, Inc.
K042479 09/13/2004 VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE Ortho-Clinical Diagnostics, Inc.
K042476 09/13/2004 VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS Ortho-Clinical Diagnostics, Inc.
K042520 09/16/2004 VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc.
K043384 12/09/2004 VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc.
K043386 12/09/2004 VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc.
K982649 07/30/1998 VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III Ortho-Clinical Diagnostics, Inc.
K033300 10/14/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K063143 10/16/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc.
K190326 02/13/2019 VITROS XT Chemistry Products UREA-CREA Slides Ortho-Clinical Diagnostics, Inc.
K190520 03/04/2019 VITROS XT Chemistry Products GLU-Ca Slides Ortho-Clinical Diagnostics, Inc.
K210858 03/23/2021 VITROS Chemistry Products PHBR Slides Ortho-Clinical Diagnostics, Inc.
K190807 03/29/2019 VITROS XT Chemistry Products TBIL-ALKP Slides Ortho-Clinical Diagnostics, Inc.
K001266 04/20/2000 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA Ortho-Clinical Diagnostics, Inc.
K191316 05/15/2019 VITROS XT Chemistry Products ALB-TP Slides Ortho-Clinical Diagnostics, Inc.
K160495 02/22/2016 VITROS« Automation Solutions Ortho-Clinical Diagnostics, Inc.
K030626 02/27/2003 VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 Ortho-Clinical Diagnostics, Inc.
K061464 05/25/2006 VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 Ortho-Clinical Diagnostics, Inc.
K062094 07/24/2006 VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V Ortho-Clinical Diagnostics, Inc.
K042006 07/26/2004 VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE Ortho-Clinical Diagnostics, Inc.
K062285 08/07/2006 VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV Ortho-Clinical Diagnostics, Inc.
K062637 09/05/2006 VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V Ortho-Clinical Diagnostics, Inc.
K042477 09/13/2004 VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN Ortho-Clinical Diagnostics, Inc.
K042643 09/27/2004 VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II Ortho-Clinical Diagnostics, Inc.
K052819 10/04/2005 VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc.
K052867 10/11/2005 VITROS CHEMISTRY PRODUCTS DTIBC REAGENT Ortho-Clinical Diagnostics, Inc.
K042838 10/14/2004 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II Ortho-Clinical Diagnostics, Inc.
K121608 06/01/2012 VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS Ortho-Clinical Diagnostics, Inc.
K130332 02/11/2013 VITROS CHEMISTRY PRODUCTS TRIG SLIDES Ortho-Clinical Diagnostics, Inc.
K120765 03/13/2012 VITROS CHEMISTRY PRODUCTS ECO2 SLIDES Ortho-Clinical Diagnostics, Inc.
K000566 02/22/2000 MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS Ortho-Clinical Diagnostics, Inc.
K060632 03/09/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 Ortho-Clinical Diagnostics, Inc.
K081543 06/02/2008 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM Ortho-Clinical Diagnostics, Inc.
K060940 04/06/2006 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III Ortho-Clinical Diagnostics, Inc.
K161140 04/22/2016 VITROS Chemistry Products Calibrator Kit 3 ORTHO-CLINICAL DIAGNOSTICS, INC.
K071801 07/02/2007 VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 Ortho-Clinical Diagnostics, Inc.
K182063 08/01/2018 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System Ortho-Clinical Diagnostics, Inc.
K182072 08/01/2018 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides Ortho-Clinical Diagnostics, Inc.
K072440 08/30/2007 VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) Ortho-Clinical Diagnostics, Inc.
K072443 08/30/2007 VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY Ortho-Clinical Diagnostics, Inc.
K042475 09/13/2004 VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC Ortho-Clinical Diagnostics, Inc.
DEN210038 09/20/2021 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator Ortho-Clinical Diagnostics, Inc.
DEN210040 09/21/2021 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators Ortho-Clinical Diagnostics, Inc.
K073157 11/08/2007 VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc.
K001133 04/10/2000 VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc.
K001885 06/21/2000 VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc.
K984303 12/02/1998 VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT Ortho-Clinical Diagnostics, Inc.
K120609 02/29/2012 VITROS CHEMISTRY PRODUCTS DHDL SLIDES Ortho-Clinical Diagnostics, Inc.
K081411 05/20/2008 VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc.
K091861 06/19/2009 VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 Ortho-Clinical Diagnostics, Inc.
K041720 06/24/2004 VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II Ortho-Clinical Diagnostics, Inc.
K041863 07/09/2004 VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS Ortho-Clinical Diagnostics, Inc.
K062077 07/21/2006 VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K082099 07/25/2008 VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 Ortho-Clinical Diagnostics, Inc.
K062460 08/23/2006 VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc.
K042521 09/16/2004 VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K023876 11/21/2002 VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc.
K023875 11/21/2002 VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 Ortho-Clinical Diagnostics, Inc.
K093611 11/23/2009 VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; Ortho-Clinical Diagnostics, Inc.
K083680 12/12/2008 VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 Ortho-Clinical Diagnostics, Inc.
K001310 04/25/2000 VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc.
K001679 06/01/2000 VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 Ortho-Clinical Diagnostics, Inc.
K992349 07/14/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K992366 07/15/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK Ortho-Clinical Diagnostics, Inc.
K012593 08/10/2001 VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc.
K984288 12/01/1998 VITROS CHEMISTRY PRODUCTS PHBR SLIDES Ortho-Clinical Diagnostics, Inc.
K994145 12/08/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS Ortho-Clinical Diagnostics, Inc.
K061588 06/08/2006 VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K060650 03/13/2006 VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 Ortho-Clinical Diagnostics, Inc.
K071216 05/02/2007 VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 Ortho-Clinical Diagnostics, Inc.
K071215 05/02/2007 VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 Ortho-Clinical Diagnostics, Inc.
K062123 07/25/2006 VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV Ortho-Clinical Diagnostics, Inc.
K063164 10/18/2006 VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV Ortho-Clinical Diagnostics, Inc.
K063591 12/01/2006 VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 Ortho-Clinical Diagnostics, Inc.
K123930 12/20/2012 VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc.
K060678 03/14/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS Ortho-Clinical Diagnostics, Inc.
K060770 03/22/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS Ortho-Clinical Diagnostics, Inc.
K041322 05/18/2004 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc.
K032993 09/25/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS Ortho-Clinical Diagnostics, Inc.
K063144 10/16/2006 VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM Ortho-Clinical Diagnostics, Inc.
K032296 07/25/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc.
K003112 10/04/2000 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS Ortho-Clinical Diagnostics, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact