Medical Device Manufacturer · US , Ocean , NJ

Immunostics Inc., - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1997

14

Total

14

Cleared

0

Denied

FDA 510(k) cleared devices by Immunostics Inc., Chemistry ✕

3 devices

1-3 of 3

Cleared Sep 22, 2023

ALFIS Vitamin D, ALFIS-3 Analyzer

Chemistry · 457d

Cleared Aug 11, 2004

HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

Chemistry · 47d

Cleared Aug 29, 1997

PREGNACOL PREGNANCY TEST

Chemistry · 49d