K253082
- 510(k) number
- K253082
- Device name
- LZI Buprenorphine II Enzyme Immunoassay
- Applicant
- Lin-Zhi International, Inc. CA · US
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2026-01-16
- Date received
- 2025-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 6.6 MB · U.S. public domain
Also available from FDA: K253082.pdf
Official FDA record: K253082
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.