Medical Device Manufacturer · US , Star , ID

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

5 submissions · 4 cleared · Since 2016

5

Total

4

Cleared

1

Denied

FDA 510(k) Regulatory Record - Kronus, Inc. Chemistry ✕

2 devices

1-2 of 2

Cleared Aug 24, 2023

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

Chemistry · 590d

Cleared Jan 19, 2018

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

Chemistry · 221d