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FDA 510(k) K220046 — Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
FDA 510(k) index record K220046. Device: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11. Applicant as listed: Shenzhen Superbio Technology Co., Ltd.. Decision date: 2022-12-13.
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"device_name": "Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K220046.
Device name: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11. Applicant as listed: Shenzhen Superbio Technology Co., Ltd..
Decision date: 2022-12-13. 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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