Source document or public record
FDA 510(k) K250609 — Sober Self-Test
FDA 510(k) index record K250609. Device: Sober Self-Test. Applicant as listed: Sober Ip, LLC. Decision date: 2025-09-15.
Source
"device_name": "Sober Self-Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K250609.
Device name: Sober Self-Test. Applicant as listed: Sober Ip, LLC.
Decision date: 2025-09-15. Decision wording: Substantially Equivalent.
Product code: DIC. Regulation: 21 CFR 862.3040. Medical specialty: Clinical Toxicology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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