Ortho-Clinical Diagnostics - FDA 510(k) Cleared Devices
38
Total
38
Cleared
0
Denied
FDA 510(k) cleared devices by Ortho-Clinical Diagnostics Microbiology ✕
7 devices
Cleared
Aug 28, 2024
VITROS Immunodiagnostic Products Syphilis Reagent Pack
Microbiology
90d
Cleared
Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
Microbiology
26d
Cleared
Dec 14, 2005
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323
Microbiology
79d
Cleared
Sep 27, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
Microbiology
33d
Cleared
Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
Microbiology
31d
Cleared
Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
Microbiology
10d
Cleared
Aug 29, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
Microbiology
21d