Medical Device Manufacturer · US , Morris Plains , NJ

Euroimmun US - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 2012

12

Total

11

Cleared

1

Denied

FDA 510(k) Regulatory Record - Euroimmun US Microbiology ✕

2 devices

1-2 of 2

Cleared Aug 25, 2016

Anti-Borrelia burgdorferi US Westernblot (IgG)

Microbiology · 84d

Cleared May 04, 2015

EUROIMMUN LYME ELISA(IgG/IgM)

Microbiology · 280d