Selux Diagnostics, Inc. FDA Approvals

0 new drug approvals and 4 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
PBC Separator with Selux AST System510(k)Mar 28, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2025
PBC Separator with Selux AST System510(k)Feb 15, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Feb 15, 2024
Selux AST System; Model AST Gen 1.0510(k)Apr 19, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 19, 2023
Selux AST System; Model AST Gen 1.0510(k)Jan 18, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 18, 2023