K252684
- 510(k) number
- K252684
- Device name
- Labcorp Fentanyl Urine Visual Test
- Applicant
- Medtox Diagnostics, Inc. NC · US
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2026-01-29
- Date received
- 2025-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K252684.pdf
Official FDA record: K252684
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.