Sober Self-Test
FDA 510(k) clearance K250609 · decided 2025-09-15
Clearance details
- K-number
- K250609
- Device name
- Sober Self-Test
- Applicant
- Sober Ip, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-02-28
- Decision date
- 2025-09-15
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- DIC
- Device class
- 2
- Regulation number
- 862.3040
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Southfield, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.