Source document or public record
FDA 510(k) K251634 — LZI Fentanyl III Enzyme Immunoassay
FDA 510(k) index record K251634. Device: LZI Fentanyl III Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc.. Decision date: 2025-06-18.
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"device_name": "LZI Fentanyl III Enzyme Immunoassay"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K251634.
Device name: LZI Fentanyl III Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc..
Decision date: 2025-06-18. Decision wording: Substantially Equivalent.
Product code: DJG. Regulation: 21 CFR 862.3650. Medical specialty: Clinical Toxicology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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