The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Preview Digital Pregnancy Test.
| Device ID | K173229 |
| 510k Number | K173229 |
| Device Name: | Preview Digital Pregnancy Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. No.8 Lizhishan Road, Science City Guangzhou, CN 510641 |
| Contact | Bin Chen |
| Correspondent | Joe Shia LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-04 |
| Decision Date | 2018-03-12 |
| Summary: | summary |