Medical Device Manufacturer · DE , Holzgerlingen

Curetis GmbH - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2018

Recent clearances: Unyvero LRT BAL Application

View 2 510(k) Devices ↓

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Curetis GmbH Microbiology ✕

2 devices

1-2 of 2

Cleared Dec 20, 2019

Unyvero LRT BAL Application

Microbiology · 150d

Not Cleared Apr 03, 2018

Curetis Unyvero LRT Application

DEN170047 · QBH

Microbiology · 204d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Jun 03, 2026