Weihai Kangzhou Biotechnology Engineering Co., Ltd. · Class II · Cleared Jan 10, 2019
| K-number | K183097 |
| Device name | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream |
| Applicant | Weihai Kangzhou Biotechnology Engineering Co., Ltd. |
| Product code | LCX |
| Device class | Class II |
| Decision date | Jan 10, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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