FDA 510(k) Applications for Medical Device Product Code "NFT"
(Test, Amphetamine, Over The Counter)

FDA 510(k) Number Applicant Device Name Decision Date
K170049 ASSURE TECH (HANGZHOU) CO., LTD. AssureTech Panel Dip Test, AssureTech Quick Cup Test 05/02/2017
K181768 Assure Tech (Hangzhou) Co., Ltd. AssureTech Panel Dip Tests, AssureTech Quick Cup Tests 08/20/2018
K180349 Assure Tech (Hangzhou) Co., Ltd. AssureTech Panel Dip Tests, AssureTech Quick Cup Tests 04/05/2018
K182701 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Cup Multi-Drug Urine Test Cup 12/03/2018
K202567 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 09/25/2020
K191841 Healstone Biotech Inc Accurate Multi Panel Drug Urine Test Cup 08/07/2019
K221871 Healstone Biotech Inc Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx 08/30/2022
K220685 Qingdao HIGHTOP Biotech Co., Ltd. HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx 05/05/2022
K201120 Safecare Biotech(Hangzhou)Co.,Ltd. SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card 05/27/2020
K181968 Safecare Biotech(Hangzhou)Co.,Ltd. SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card 08/20/2018
K202453 Safecare Biotech(Hangzhou)Co.,Ltd. SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card 03/24/2021
K182530 Shenzhen Bioeasy Biotechnology Co.,Ltd. BIOEASY Multi-Drug Test Cup 11/09/2018
K222667 Vivachek Biotech (Hangzhou) Co., Ltd Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx 11/10/2022
K171695 W.H.P.M., Inc. First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana 02/05/2018


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