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FDA 510(k) K192299 — LZI Cotinine II Enzyme Immunoassay
FDA 510(k) index record K192299. Device: LZI Cotinine II Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc.. Decision date: 2019-11-21.
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"device_name": "LZI Cotinine II 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 K192299.
Device name: LZI Cotinine II Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc..
Decision date: 2019-11-21. Decision wording: Substantially Equivalent.
Product code: MKU. Regulation: 21 CFR 862.3220. 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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