Wholepower Biotech Co., Ltd. · Class II · Cleared Apr 15, 2019
| K-number | K190705 |
| Device name | WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream |
| Applicant | Wholepower Biotech Co., Ltd. |
| Product code | LCX |
| Device class | Class II |
| Decision date | Apr 15, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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