Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices
106
Total
104
Cleared
2
Denied
106 devices
Cleared
Feb 07, 2005
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM...
Chemistry
60d
Cleared
Feb 07, 2005
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE...
Toxicology
60d
Cleared
Jan 06, 2005
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS
Toxicology
115d
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 30, 2004
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I,...
Toxicology
75d
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
Nov 10, 2004
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS
Immunology
58d
Cleared
Oct 28, 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
Chemistry
94d
Cleared
Sep 20, 2004
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
Immunology
73d
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
Jun 17, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
Immunology
30d
Cleared
Nov 05, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
Chemistry
22d
Cleared
Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
Microbiology
36d
Cleared
Sep 29, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
Chemistry
181d
Cleared
Aug 13, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
Chemistry
19d
Cleared
Mar 18, 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
Immunology
19d
Cleared
Dec 10, 2002
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
Chemistry
19d
Cleared
Dec 10, 2002
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Toxicology
19d
Cleared
Aug 30, 2001
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY...
Chemistry
20d
Cleared
Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
Microbiology
50d
Cleared
Nov 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
Microbiology
29d
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