FDA 510(k) Applications for Medical Device:
Test, Amphetamine, Over The Counter

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K170049 ASSURE TECH (HANGZHOU) CO., LTD. NO.10, XIYUANSAN RD.
HANGZHOU 310030
K181768 Assure Tech (Hangzhou) Co., Ltd. 2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road
Hangzhou 310011
K180349 Assure Tech (Hangzhou) Co., Ltd. No. 10, Xiyuansan Rd., Westlake Economic Zone
Hangzhou 310030
K182701 Guangzhou Wondfo Biotech Co., Ltd. No.8 Lizhishan Road, Science City
Guangzhou 510641
K202567 Guangzhou Wondfo Biotech Co., Ltd. No. 8 Lizhishan Road, Science City
Guangzhou 510641
K191841 Healstone Biotech Inc Unit 650 - 655 West Kent Avenue North
Vancouver V6P 6T7
K221871 Healstone Biotech Inc Unit 650 - 655 West Kent Avenue North
Vancouver V6P 6T7
K220685 Qingdao HIGHTOP Biotech Co., Ltd. No.369 Hedong Road, Hi-tech Industrial Development Zone
Qingdao 266112
K201120 Safecare Biotech(Hangzhou)Co.,Ltd. Building 2/203 No.18 Haishu Rd.,Cangqian Sub-district,
Hangzhou 311121
K181968 Safecare Biotech(Hangzhou)Co.,Ltd. Building 2/203 No.18 Haishu Rd.
Hangzhou 311121
K202453 Safecare Biotech(Hangzhou)Co.,Ltd. Building 2/203 No.18 Haishu Rd., Cangqian Sub-district
Hangzhou 311121
K182530 Shenzhen Bioeasy Biotechnology Co.,Ltd. No.2-1, Liuxian 1st Road, Xin'an Sub-District
Shenzhen 518101
K222667 Vivachek Biotech (Hangzhou) Co., Ltd Level 2, Block 2, 146 East Chaofeng Road
Hangzhou 311100
K171695 W.H.P.M., Inc. 5358 Irwindale Ave.
Irwindale CA 91706




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