Zeus Scientific FDA Approvals

0 new drug approvals and 7 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
Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM510(k)Aug 21, 2026Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Aug 21, 2026
Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB510(k)May 8, 2026Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	May 8, 2026
Alegria Flash CTD Screen510(k)Oct 22, 2025Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Oct 22, 2025
Alegria Flash ENA Screen510(k)Sep 19, 2025Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 19, 2025
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)510(k)May 7, 2025Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	May 7, 2025
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine510(k)Aug 31, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Aug 31, 2023
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit510(k)Jul 13, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 13, 2023