Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices
106
Total
104
Cleared
2
Denied
72 devices
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 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
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 06, 2006
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
Chemistry
24d
Cleared
Dec 23, 2005
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
Chemistry
73d
Cleared
Feb 07, 2005
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM...
Chemistry
60d
Cleared
Dec 09, 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
Chemistry
56d
Cleared
Dec 01, 2004
VITROS CHEMISTRY PRODUCTS VALP REAGENT
Chemistry
79d
Cleared
Nov 19, 2004
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT
Chemistry
67d
Cleared
Nov 18, 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22...
Chemistry
63d
Cleared
Nov 18, 2004
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE...
Chemistry
52d
Cleared
Oct 28, 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
Chemistry
94d
Cleared
Aug 25, 2004
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1...
Chemistry
62d
Cleared
Aug 25, 2004
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
Chemistry
54d
Cleared
Nov 05, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
Chemistry
22d