Source document or public record
FDA 510(k) K261409 — BioTeke® Multi-Drug Urine Test Cup
FDA 510(k) index record K261409. Device: BioTeke® Multi-Drug Urine Test Cup. Applicant as listed: Bioteke Corporation (Wuxi) Co., Ltd.. Decision date: 2026-09-10.
Source
"device_name": "BioTeke® Multi-Drug Urine Test Cup"
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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K261409.
Device name: BioTeke® Multi-Drug Urine Test Cup. Applicant as listed: Bioteke Corporation (Wuxi) Co., Ltd..
Decision date: 2026-09-10. Decision wording: Substantially Equivalent.
Product code: NFT. Regulation: 21 CFR 862.3100. 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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