Access Bio, Inc. 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
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test510(k)Aug 22, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 22, 2025
CareSuperb COVID-19 Antigen Home Test510(k)Jan 29, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 29, 2025