K250609
- 510(k) number
- K250609
- Device name
- Sober Self-Test
- Applicant
- Sober Ip, LLC MI · US
- Product code
- DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol
- Decision date
- 2025-09-15
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K250609.pdf
Official FDA record: K250609
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.