K252520
- 510(k) number
- K252520
- Device name
- SEFRIA Hydrocodone Oral Fluid
- Applicant
- Immunalysis Corporation CA · US
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2025-09-11
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252520.pdf
Official FDA record: K252520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.