FDA 510(k) Applications Submitted by MICHAEL 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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