Precision Biologic, Inc. 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
CRYOcheck Chromogenic Factor VIII510(k)Aug 25, 2025Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Aug 25, 2025
CRYOcheck Factor VIII Deficient Plasma with VWF510(k)Sep 13, 2023Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2023
CRYOcheck Chromogenic Factor IX510(k)Dec 23, 2022Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Dec 23, 2022