Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices
106
Total
104
Cleared
2
Denied
FDA 510(k) cleared devices by Ortho-Clinical Diagnostics, Inc. Immunology ✕
18 devices
Cleared
Apr 24, 2006
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS...
Immunology
18d
Cleared
Dec 23, 2005
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE...
Immunology
80d
Cleared
Nov 10, 2004
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS
Immunology
58d
Cleared
Sep 20, 2004
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
Immunology
73d
Cleared
Jun 17, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
Immunology
30d
Cleared
Mar 18, 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
Immunology
19d
Cleared
Mar 09, 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO...
Immunology
16d
Cleared
Jun 01, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC...
Immunology
71d
Cleared
May 19, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
Immunology
135d
Cleared
May 14, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS...
Immunology
193d
Cleared
Apr 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
Immunology
15d
Cleared
Mar 25, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE...
Immunology
16d
Cleared
Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC...
Immunology
101d
Cleared
Feb 02, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC...
Immunology
104d
Cleared
Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC...
Immunology
24d
Cleared
Jan 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
Immunology
50d
Cleared
Dec 18, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
Immunology
109d
Cleared
Oct 22, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN...
Immunology
48d