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510(k) K250609

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2025
Date Received
February 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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  • K071811 — ETOH FLEX REAGENT CARTRIDGE (DF22) (August 24, 2007)
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  • K061792 — DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FL (July 18, 2006)