Plasmapp Co,., Ltd.
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories3
Latest FDA decision2023-05-25
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K231169 | 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) | MLR | 2023-05-25 | View |
| 510(k) | K223025 | Tyvek Roll with CI for STERLINK Sterilizer | FRG | 2023-05-09 | View |
| 510(k) | K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | MLR | 2023-05-09 | View |
| 510(k) | K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | 2023-05-09 | View |
| 510(k) | K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | MLR | 2023-04-14 | View |
| 510(k) | K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | FRG | 2021-10-22 | View |
| 510(k) | K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | 2021-10-22 | View |
| 510(k) | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | MLR | 2021-10-22 | View |
No matching devices.