Documento fuente o registro público
FDA 510(k) K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
FDA 510(k) index record K201442. Device: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers. Applicant as listed: Diatron Group. Decision date: 2020-07-31.
Fuente
"device_name": "Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K201442.
Device name: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers. Applicant as listed: Diatron Group.
Decision date: 2020-07-31. Decision wording: Substantially Equivalent.
Product code: LAF. Regulation: 21 CFR 862.3610. 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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