K251634
- 510(k) number
- K251634
- Device name
- LZI Fentanyl III Enzyme Immunoassay
- Applicant
- Lin-Zhi International, Inc. CA · US
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2025-06-18
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K251634.pdf
Official FDA record: K251634
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.