Sober Self-Test— 510(k) K250609

Substantially Equivalent

Sober Ip, LLC

FDA 510(k) clearance K250609 for Sober Self-Test, Substantially Equivalent on 2025-09-15. Applicant: Sober Ip, LLC. Device class: 2.

Clearance details

Applicant: Sober Ip, LLC
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 2025-02-28
Decision date: 2025-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southfield, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.