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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
510(k) Number K250609
Device Name Sober Self-Test
Applicant
Sober Ip, LLC
27694 Franklin Rd.
Southfield,  MI  48034
Applicant Contact Timothy Downey
Correspondent
Synergy Bioscience
10944 Alder Cir.
Dallas,  TX  75238
Correspondent Contact Shadeed Salem
Regulation Number862.3040
Classification Product Code
DIC  
Date Received02/28/2025
Decision Date 09/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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