FDA 510(k) Applications for Medical Device:
Test, Amphetamine, Over The Counter
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K242498 | Aicheck Biotech, Inc. |
17701 Cowan Ste 230 | Irvine | CA | 92614 |
| K242077 | Aicheck Biotech, Inc. |
17701 Cowan, Ste 230 | Irvine | CA | 92614 |
| 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 | |
| K243996 | Assure Tech LLC |
1521 Concord Pike, Suite 201 | Wilmington | DE | 19803 |
| 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 | |
| K244043 | Hangzhou Alltest Biotech Co.,Ltd |
#550, Yinhai Street | Hangzhou | 310018 | |
| K250727 | Hangzhou Alltest Biotech Co.,Ltd |
#550, Yinhai Street | Hangzhou | 310018 | |
| K241428 | Hangzhou Alltest Biotech Co.,Ltd |
#550, Yinhai Street | Hangzhou | 310018 | |
| K242540 | Hangzhou Alltest Biotech Co.,Ltd |
#550, Yinhai Street | Hangzhou | 310018 | |
| 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 | |
| K233062 | VivaChek Biotech (Hangzhou) Co., Ltd |
Level 2, Block 2, 146 East Chaofeng Rd., | Hangzhou | 311100 | |
| 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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