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

FDA 510(k) Number Submission Date Device Name Applicant
K020662 03/01/2002 MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS
K024193 12/20/2002 MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS
K041764 06/30/2004 THE VITROS 5,1 FS CHEMISTRY SYSTEM ORTHO-CLINICAL DIAGNOSTICS
K062838 09/21/2006 VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 ORTHO-CLINICAL DIAGNOSTICS
K011463 05/14/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS
K001769 06/12/2000 VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT ORTHO-CLINICAL DIAGNOSTICS
K042494 09/14/2004 VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III ORTHO-CLINICAL DIAGNOSTICS
K101921 07/09/2010 VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT ORTHO-CLINICAL DIAGNOSTICS
K060480 02/23/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS ORTHO-CLINICAL DIAGNOSTICS
K083173 10/27/2008 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM ORTHO-CLINICAL DIAGNOSTICS
K062165 07/28/2006 VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS
K022901 09/03/2002 VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS
K993068 09/13/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS
K013899 11/23/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS
K013900 11/23/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS
K052645 09/26/2005 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; ORTHO-CLINICAL DIAGNOSTICS
K031924 06/23/2003 VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 ORTHO-CLINICAL DIAGNOSTICS
K063720 12/15/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS
K042303 08/25/2004 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS ORTHO-CLINICAL DIAGNOSTICS
K030067 01/07/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS ORTHO-CLINICAL DIAGNOSTICS
K033127 09/30/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS ORTHO-CLINICAL DIAGNOSTICS
K012561 08/08/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS ORTHO-CLINICAL DIAGNOSTICS


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