Horiba Abx Sas FDA Approvals

0 new drug approvals and 3 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
Yumizen H550510(k)Sep 14, 2026Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Sep 14, 2026
Yumizen H2500510(k)May 21, 2024Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	May 21, 2024
Yumizen C1200 Creatinine PAP510(k)May 10, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 10, 2021