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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