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NFT — Test, Amphetamine, Over The Counter Class II

FDA Device Classification

Classification Details

Product Code
NFT
Device Class
Class II
Regulation Number
862.3100
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K260355webest biotechWebest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupMarch 9, 2026
K252550guangzhou wondfo biotech coSAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test CNovember 18, 2025
K252867advin biotechVINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupOctober 9, 2025
K252554vivachek biotech (hangzhou) coWisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupSeptember 12, 2025
K252118hangzhou clongene biotech coCLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupAugust 27, 2025
K252259assure techAssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupAugust 15, 2025
K250727hangzhou alltest biotech coAllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupApril 4, 2025
K244043hangzhou alltest biotech coAllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupFebruary 27, 2025
K243996assure techAssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug UrFebruary 7, 2025
K242498aicheck biotechPocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTCOctober 1, 2024
K242540hangzhou alltest biotech coAllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelSeptember 27, 2024
K242077aicheck biotechPocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test CupAugust 14, 2024
K241428hangzhou alltest biotech coAllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupJune 17, 2024
K233062vivachek biotech (hangzhou) coBioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RNovember 2, 2023
K222667vivachek biotech (hangzhou) coWisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxNovember 10, 2022
K221871healstone biotechHealstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) DrAugust 30, 2022
K220685qingdao hightop biotech coHIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup RxMay 5, 2022
K202453safecare biotech (hangzhou) coSAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardMarch 24, 2021
K202567guangzhou wondfo biotech coWondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test PanSeptember 25, 2020
K201120safecare biotech (hangzhou) coSAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardMay 27, 2020