Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices
106
Total
104
Cleared
2
Denied
106 devices
Cleared
Jul 20, 2000
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS...
Chemistry
29d
Cleared
Jun 28, 2000
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
Chemistry
27d
Cleared
May 05, 2000
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR...
Chemistry
10d
Cleared
May 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE...
Chemistry
12d
Cleared
Apr 24, 2000
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
Chemistry
14d
Cleared
Mar 09, 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO...
Immunology
16d
Cleared
Dec 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS...
Chemistry
14d
Cleared
Oct 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
Chemistry
85d
Cleared
Aug 24, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
Chemistry
41d
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
Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
Chemistry
21d
Cleared
Feb 05, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS...
Chemistry
77d
Cleared
Feb 02, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC...
Immunology
104d
Cleared
Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX...
Chemistry
101d
Cleared
Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC...
Immunology
24d
Cleared
Jan 28, 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
Chemistry
57d
Cleared
Jan 26, 1999
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
Toxicology
56d
Cleared
Jan 25, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
Chemistry
17d
Cleared
Jan 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
Immunology
50d
Cleared
Dec 29, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
Chemistry
50d
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