Medical Device Manufacturer · US , Rochester , NY

Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices

106 submissions · 104 cleared · Since 1997
106
Total
104
Cleared
2
Denied
72 devices
26-50 of 72
Cleared May 25, 2007
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT...
K071215 · JFY
Chemistry · 23d
Cleared May 25, 2007
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT...
K071216 · JFY
Chemistry · 23d
Cleared Dec 22, 2006
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
K062285 · JXM
Chemistry · 137d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE...
K062460 · DJG
Chemistry · 114d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY...
K063591 · JFY
Chemistry · 14d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · DKZ
Chemistry · 124d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1,...
K062094 · LCM
Chemistry · 121d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE,...
K062637 · DJR
Chemistry · 78d
Cleared Nov 16, 2006
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
K062123 · DIO
Chemistry · 114d
Cleared Nov 13, 2006
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
K063144 · JJE
Chemistry · 28d
Cleared Jul 21, 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K061588 · LPS
Chemistry · 43d
Cleared Jun 15, 2006
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464 · JMO
Chemistry · 21d
Cleared Jun 06, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE...
K060632 · NBC
Chemistry · 89d
Cleared Apr 06, 2006
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
K060650 · LCP
Chemistry · 24d
Cleared Dec 23, 2005
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
K052867 · JMO
Chemistry · 73d
Cleared Feb 07, 2005
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM...
K043384 · LDO
Chemistry · 60d
Cleared Dec 09, 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
K042838 · JIT
Chemistry · 56d
Cleared Dec 01, 2004
VITROS CHEMISTRY PRODUCTS VALP REAGENT
K042476 · LEG
Chemistry · 79d
Cleared Nov 19, 2004
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT
K042477 · DDG
Chemistry · 67d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22...
K042521 · JIT
Chemistry · 63d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE...
K042643 · DCF
Chemistry · 52d
Cleared Oct 28, 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K042006 · LBS
Chemistry · 94d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1...
K041720 · MRR
Chemistry · 62d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K041799 · NQD
Chemistry · 54d
Cleared Nov 05, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
K033300 · DDR
Chemistry · 22d
Filters