Plasmapp Co,., Ltd. · Class II · Cleared May 25, 2023
| K-number | K231169 |
| Device name | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
| Applicant | Plasmapp Co,., Ltd. |
| Product code | MLR |
| Device class | Class II |
| Decision date | May 25, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 880.6860 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov