Medical Device Manufacturer · US , Branchburg , NJ

Zeus Scientific - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2023

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Zeus Scientific Immunology ✕

4 devices

1-4 of 4

Cleared Oct 22, 2025

Alegria Flash CTD Screen

Immunology · 231d

Cleared Sep 19, 2025

Alegria Flash ENA Screen

Immunology · 218d

Cleared May 07, 2025

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed)

Immunology · 149d

Cleared Aug 31, 2023

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

Immunology · 90d