Replies to post #10355 on DarioHealth Corp (DRIO)

[TRUMPSTER!]

Good point. No slam dunk but high probability of approval. We saw a FDA 510 (k) in this same market approved after 14 months. Our approval process started Dec 2013. So, I think the company was cautious by telling everyone their looking for approval early 2015.

[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