LABSTYLE INNOVATIONS

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0260-2020Class IIDario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.August 29, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K163159Dario Blood Glucose Monitoring SystemJuly 19, 2017
K150817Dario Blood Glucose Monitoring SystemDecember 21, 2015