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

FDA 510(k) cleared devices by Ortho-Clinical Diagnostics, Inc. Microbiology ✕

9 devices

1-9 of 9

Not Cleared May 05, 2023

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS...

DEN210038 · QVP

Microbiology · 592d

Not Cleared May 05, 2023

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS...

DEN210040 · QVP

Microbiology · 591d

Cleared Apr 15, 2009

ORTHO T. CRUZI ELISA TEST SYSTEM

Microbiology · 567d

Cleared Dec 26, 2006

VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS

Microbiology · 71d

Cleared Sep 15, 2006

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND...

Microbiology · 177d

Cleared Sep 14, 2006

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS

Microbiology · 184d

Cleared Oct 31, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS

Microbiology · 36d

Cleared Jun 13, 2001

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

Microbiology · 50d

Cleared Nov 02, 2000

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

Microbiology · 29d