Source document or public record
FDA 510(k) K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
FDA 510(k) index record K231137. Device: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard. Applicant as listed: Xenta Biomedical Science Co., Ltd.. Decision date: 2023-05-19.
Source
"device_name": "Xenta Drug Screen Cup, Xenta Drug Screen Dipcard"
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 K231137.
Device name: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard. Applicant as listed: Xenta Biomedical Science Co., Ltd..
Decision date: 2023-05-19. Decision wording: Substantially Equivalent.
Product code: DKZ. 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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