Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices
106
Total
104
Cleared
2
Denied
106 devices
Cleared
Dec 07, 2007
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
Chemistry
29d
Cleared
Sep 24, 2007
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
Chemistry
25d
Cleared
Sep 20, 2007
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1...
Chemistry
21d
Cleared
Jul 20, 2007
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207,...
Chemistry
18d
Cleared
May 25, 2007
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT...
Chemistry
23d
Cleared
May 25, 2007
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT...
Chemistry
23d
Cleared
Dec 28, 2006
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1,...
Toxicology
71d
Cleared
Dec 26, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
Microbiology
71d
Cleared
Dec 22, 2006
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
Chemistry
137d
Cleared
Dec 15, 2006
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE...
Chemistry
114d
Cleared
Dec 15, 2006
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY...
Chemistry
14d
Cleared
Nov 22, 2006
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
Chemistry
124d
Cleared
Nov 22, 2006
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1,...
Chemistry
121d
Cleared
Nov 22, 2006
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE,...
Chemistry
78d
Cleared
Nov 16, 2006
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
Chemistry
114d
Cleared
Nov 13, 2006
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
Chemistry
28d
Cleared
Sep 15, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND...
Microbiology
177d
Cleared
Sep 14, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
Microbiology
184d
Cleared
Jul 21, 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
Chemistry
43d
Cleared
Jun 15, 2006
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
Chemistry
21d
Cleared
Jun 06, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE...
Chemistry
89d
Cleared
Apr 24, 2006
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS...
Immunology
18d
Cleared
Apr 06, 2006
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
Chemistry
24d
Cleared
Dec 23, 2005
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE...
Immunology
80d
Cleared
Dec 23, 2005
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
Chemistry
73d
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