FDA 510(k) Clearance Decision Summary For Healthy.io Minuteful Kidney Application

On July 6, 2022, the U.S. Food and Drug Administration (FDA) released this summary of the FDA's decision to issue Healthy.io 510(k) Clearance to market its Minuteful kidney medical test for chronic kidney disease. The Minuteful kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR . . .