FDA 510(k) Applications Submitted by MARLENE HANNA

FDA 510(k) Number Submission Date Device Name Applicant
K160712 03/15/2016 VITROS Chemistry Products hsCRP Reagent Ortho Clinical Diagnostics
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.
K162020 07/21/2016 VITROS Chemistry Products Cl- Slides Ortho Clinical Diagnostics
K062165 07/28/2006 VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS
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.
K022901 09/03/2002 VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS
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.
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.
K023875 11/21/2002 VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 Ortho-Clinical Diagnostics, Inc.
K023876 11/21/2002 VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 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.


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