Ortho-Clinical Diagnostics - FDA 510(k) Cleared Devices
38
Total
38
Cleared
0
Denied
38 devices
Cleared
Sep 09, 2004
THE VITROS 5,1 FS CHEMISTRY SYSTEM
Chemistry
71d
Cleared
Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
Microbiology
31d
Cleared
Aug 07, 2003
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK,...
Chemistry
45d
Cleared
Feb 21, 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT...
Chemistry
63d
Cleared
Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
Microbiology
10d
Cleared
Sep 27, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
Chemistry
24d
Cleared
Apr 12, 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/...
Chemistry
42d
Cleared
Jan 24, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
Toxicology
62d
Cleared
Dec 21, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
Toxicology
28d
Cleared
Aug 29, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
Microbiology
21d
Cleared
Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
Chemistry
30d
Cleared
Jun 21, 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
Chemistry
9d
Cleared
Oct 04, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
Chemistry
21d