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Zeus Scientific

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories5
Latest FDA decision2026-05-08
TypeNumberDevice NameCodeDateActions
510(k) K250814 Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE2026-05-08 View
510(k) K250666 Alegria Flash CTD ScreenLLL2025-10-22 View
510(k) K250408 Alegria Flash ENA ScreenLLL2025-09-19 View
510(k) K243776 Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)MOB2025-05-07 View
510(k) K231616 ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL2023-08-31 View
510(k) K230863 ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitLSR2023-07-13 View
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