Ortho Clinical Diagnostics FDA Approvals

0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
VITROS Immunodiagnostic Products Syphilis Reagent Pack510(k)Aug 28, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 28, 2024
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack510(k)May 8, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 8, 2024
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack510(k)Sep 5, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Sep 5, 2023
VITROS Immunodiagnostic Products CEA Reagent Pack510(k)Aug 23, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Aug 23, 2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack510(k)Aug 9, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Aug 9, 2023
VITROS Immuodiagnostic Products CA 125 II Reagent Pack510(k)Dec 12, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Dec 12, 2022
VITROS AFP510(k)Jun 15, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Jun 15, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack510(k)Jan 28, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 28, 2022
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack510(k)Oct 4, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 4, 2021