FDAnews
www.fdanews.com/articles/187760-israeli-devicemaker-cleared-for-urinalysis-test
ClearanceStamp_Gray.gif

Israeli Devicemaker Cleared for Urinalysis Test

July 26, 2018

The FDA granted Healthy.io 510(k) clearance for its home-based urinalysis test Dip.io device that enables a smartphone to read urine tests.

Dip.io comes with testing cups, disposable test strips and instructions for home testing. In addition, a panel of colors and patterns allows the smartphone to read the test strip regardless of lighting.

The test kit gives immediate results for clinical-grade urine tests and does not require mailing.

View today's stories