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. Toxicology ✕

7 devices

1-7 of 7

Cleared Aug 13, 2021

VITROS Chemistry Products PHBR Slides

Toxicology · 143d

Cleared Dec 28, 2006

VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1,...

Toxicology · 71d

Cleared Feb 07, 2005

VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE...

Toxicology · 60d

Cleared Jan 06, 2005

VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS

Toxicology · 115d

Cleared Nov 30, 2004

VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I,...

Toxicology · 75d

Cleared Dec 10, 2002

VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

Toxicology · 19d

Cleared Jan 26, 1999

VITROS CHEMISTRY PRODUCTS PHBR SLIDES

Toxicology · 56d