Innovita (Tangshan) Biological Technology Co., Ltd. · Class II · Cleared Nov 22, 2019
| K-number | K192843 |
| Device name | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream |
| Applicant | Innovita (Tangshan) Biological Technology Co., Ltd. |
| Product code | LCX |
| Device class | Class II |
| Decision date | Nov 22, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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