Sober Self-Test
K-Number: K250609 · 2025-09-15
ApplicantSober Ip, LLC
Decision Date2025-09-15
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
Sober Self-Test is a medical device manufactured by Sober Ip, LLC. It received FDA 510(k) clearance on 2025-09-15 under approval number K250609. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sober Self-Test?
Sober Self-Test is a medical device that received FDA 510(k) clearance on 2025-09-15. It is manufactured by Sober Ip, LLC. The 510(k) number is K250609.
When was Sober Self-Test approved by the FDA?
Sober Self-Test received FDA 510(k) clearance on 2025-09-15, under approval number K250609.
What company makes Sober Self-Test?
Sober Self-Test is manufactured by Sober Ip, LLC.
What is the FDA product code for Sober Self-Test?
The FDA product code for Sober Self-Test is DIC.
Related Devices (Code: DIC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.