K250741
- 510(k) number
- K250741
- Device name
- Evidence MultiSTAT DOA Urine MultiPlex
- Applicant
- Randox Laboratories Limited GB
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2026-01-23
- Date received
- 2025-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K250741.pdf
Official FDA record: K250741
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.