Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)— 510(k) K223023
Substantially EquivalentPlasmapp Co,., Ltd.
FDA 510(k) clearance K223023 for Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), Substantially Equivalent on 2023-05-09. Applicant: Plasmapp Co,., Ltd..
Clearance details
- Applicant
- Plasmapp Co,., Ltd.
- Product code
- Code FRC
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daejeon, KR
Data sourced from openFDA. This site is unofficial and independent of the FDA.