Helena Laboratories, Corp. 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
SPIFE A1AT kit510(k)Oct 13, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Oct 13, 2022
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control510(k)Apr 19, 2022Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Apr 19, 2022