The following data is part of a premarket notification filed by Wholepower Biotech Co., Ltd. with the FDA for Wholepower Pregnancy Rapid Test Cassette, Wholepower Pregnancy Rapid Test Strip, Wholepower Pregnancy Rapid Test Midstream.
| Device ID | K190705 |
| 510k Number | K190705 |
| Device Name: | WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Wholepower Biotech Co., Ltd. Unit 4, Dongjun Palza, Dongfengdong Road Guangzhou, CN 510008 |
| Contact | William Gao |
| 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 | 2019-03-19 |
| Decision Date | 2019-04-15 |