Affinity Biosensors, LLC 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
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system510(k)Oct 27, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system510(k)Oct 23, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 23, 2024