DarioHealth Corp (DRIO)

[sumotrader]

Here's a good link to better understand the DRIOD 510(K) process. Investors need to know what device is the "predicate" for the application and has payment been made yet for the application? This would provide better clarity on the status of the approval given it usually only takes 90 days for a properly submitted form.

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm