510(k) K250609

Sober Self-Test by Sober Ip, LLC — Product Code DIC

K250609 is an FDA 510(k) premarket notification submitted by Sober Ip, LLC for the device "Sober Self-Test". The FDA issued a decision of Substantially Equivalent on September 15, 2025. The device falls under product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method), a Class II device regulated under 21 CFR 862.3040.