Progenika Biopharma S.A., A Grifols Company FDA Approvals

0 new drug approvals and 2 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
AlphaID At Home Genetic Health Risk Service510(k)Oct 27, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Oct 27, 2022
A1AT Genotyping Test510(k)May 13, 2021Immunology	Immunology	510(k)Substantially Equivalent (Special)	May 13, 2021