FDA 510(k) Applications Submitted by MICHAEL M BYRNE

FDA 510(k) Number Submission Date Device Name Applicant
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.
K071215 05/02/2007 VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 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.
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.
K052645 09/26/2005 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; ORTHO-CLINICAL DIAGNOSTICS
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.


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