Runbio Biotech Co.,Ltd · Class II · Cleared Feb 22, 2019
| K-number | K181551 |
| Device name | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette |
| Applicant | Runbio Biotech Co.,Ltd |
| Product code | LCX |
| Device class | Class II |
| Decision date | Feb 22, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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