Plasmapp Co,., Ltd. · Class II · Cleared Oct 22, 2021
| K-number | K212193 |
| Device name | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
| Applicant | Plasmapp Co,., Ltd. |
| Product code | FRC |
| Device class | Class II |
| Decision date | Oct 22, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 880.2800 |
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