Cleared Traditional

BIOEASY Multi-Drug Test Cup

K182530 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Toxicology
Nov 2018
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K182530 is an FDA 510(k) clearance for the BIOEASY Multi-Drug Test Cup, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 9, 2018, 56 days after receiving the submission on September 14, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K182530 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2018
Decision Date November 09, 2018
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NFT — Test, Amphetamine, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

Similar Devices — NFT Test, Amphetamine, Over The Counter

All 27
Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
K260355 · WEBEST Biotech,, LLC · Mar 2026
SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
K252550 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2025
VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
K252867 · Advin Biotech, Inc. · Oct 2025
Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
K252554 · Vivachek Biotech (Hangzhou) Co., Ltd. · Sep 2025
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
K252118 · Hangzhou Clongene Biotech Co., Ltd. · Aug 2025
AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
K252259 · Assure Tech., LLC · Aug 2025