The VivaChek™‘s 6 models BGMS were cleared by the US FDA

Update: 2018-12-24

FDA (Food and Drug Administration) is the international medical device audit authority, authorized by the US Congress, the federal government, specializing in food and drug management of the highest law enforcement agencies.

VivaChek Ino Smart

VivaChek Ino Sync

VivaChek Ino Sound

VivaChek Ino Plus

VivaChek Ino Sound Simple

VivaChek Ino Sound Bright

Blood Glucose Monitoring System got approved by the USA FDA.

Following attached the 510k certificate