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 |