Applied BioCode, 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
BioCode® Respiratory Pathogen Panel (RPP)510(k)May 1, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	May 1, 2026
BioCode Gastrointestinal Pathogen Panel (GPP)510(k)Jan 10, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 10, 2025