Medical Device Manufacturer · US , Branchburg , NJ

Zeus Scientific - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2023

Recent clearances: Alegria Flash SSA-60, Alegria Flash CTD Screen, Alegria Flash ENA Screen

6

Total

6

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared May 08, 2026

Alegria Flash SSA-60

Immunology · 417d

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