Accurate Multi Panel Drug Urine Test Cup

FDA 510(k) K191841 · Healstone Biotech, Inc.

Substantially Equivalent

510(k) numberK191841

Submission

Device name
Accurate Multi Panel Drug Urine Test Cup
Applicant
Healstone Biotech, Inc.
Vancouver, CA
Received
July 9, 2019
Decision date
August 7, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NFT – Test, Amphetamine, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3100
Specialty
Clinical Toxicology

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K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional Guangzhou Wondfo Biotech Co., Ltd.11/18/2025SE
K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupNFT · Traditional Advin Biotech, Inc.10/09/2025SE
K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupNFT · Traditional Vivachek Biotech (Hangzhou) Co., Ltd.09/12/2025SE
K252118CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupNFT · Traditional Hangzhou Clongene Biotech Co., Ltd.08/27/2025SE
K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional Assure Tech., LLC08/15/2025SE

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Questions and answers

When was Accurate Multi Panel Drug Urine Test Cup cleared by the FDA?

Accurate Multi Panel Drug Urine Test Cup (K191841) received a 510(k) decision of Substantially Equivalent on August 7, 2019, 29 days after the submission was received.

What is the product code of K191841?

The FDA product code is NFT – Test, Amphetamine, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3100.