510(k) K250609 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Sober Self-Test
| Applicant | Sober Ip, LLC, Southfield MI, US |
| Decision | Substantially Equivalent, Sep 15, 2025 |
| Received | Feb 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250609
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.