FDA 510(k) Applications for Medical Device:
Test, Opiates, Over The Counter
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K234006 | AllSource Screening Solutions |
1401 Pontiac Court | Export | PA | 15632 |
| K082898 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K100108 | AMEDICA BIOTECH, INC. |
28301 INDUSTRIAL BLVD SUITE K | HAYWARD | CA | 94545 |
| K250803 | ANHUI Deepblue Medical Technological Co., Ltd. |
Pearl Industrial Park, 106 Innovation Ave. | Hefei | 230088 | |
| K240351 | Assure Tech LLC |
1521 Concord Pike, Suite 201 | Wilmington | DE | 19803 |
| K241100 | Co-Innovation Biotech Co.,Ltd. |
No.9 Baihe 3 Street, Economic And Technological Development | Guangzhou | 510530 | |
| K243064 | Eterbio, Inc. |
420, No. 1316, Caixia Street | Zhuhai | 519000 | |
| K242428 | Guangzhou Decheng Biotechnology Co., Ltd. |
Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road | Guangzhou | 510663 | |
| K250067 | Guangzhou Decheng Biotechnology Co., Ltd. |
Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road | Guangzhou | 510663 | |
| K241741 | Guangzhou Wondfo Biotech Co., Ltd. |
No.8 Lizhishan Road, Science City, Huangpu District | Guangzhou | 510663 | |
| K233417 | Hangzhou AllTest Biotech Co.,Ltd |
#550, Yinhai Street | Hangzhou | 310018 | |
| K242802 | Hangzhou Clongene Biotech Co.,Ltd. |
No.1 Yichuang Road, Yuhang District | Hangzhou | 311121 | |
| K181790 | Hangzhou Clongene Biotech Co.,Ltd. |
Building 4, No.20 Longquan Road, Yuhang District | Hangzhou | 311121 | |
| K190412 | Hangzhou Clongene Biotech Co.,Ltd. |
Building 4, No.20 Longquan Road, Yuhang District | Hangzhou | 311121 | |
| K243365 | Healgen Scientific LLC |
3818 Fuqua St | Houston | TX | 77047 |
| K240686 | Healgen Scientific LLC |
3818 Fuqua St | Houston | TX | 77047 |
| K240949 | Healgen Scientific LLC |
3818 Fuqua St | Houston | TX | 77047 |
| K240295 | Instanosis Inc |
1004 w 9th Avenue | King of Prussia | PA | 19406 |
| K241969 | Qingdao HIGHTOP Biotech Co., Ltd. |
No.369 Hedong Road | Qingdao | 266112 | |
| K240654 | Safecare Biotech (Hangzhou) Co., Ltd. |
Building 2/203 No.18 Haishu Rd., Cangqian Sub-district | Hangzhou | 311121 | |
| K193480 | Shenzhen Bioeasy Biotechnology Co.,Ltd. |
No.2-1, Liuxian 1st Road, Xin'an Sub-District | Shenzhen | 518101 | |
| K241869 | VivaChek Biotech (Hangzhou) Co., Ltd |
Level 2, Block 2, 146 East Chaofeng Rd., | Hangzhou | 311100 |
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