Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)— 510(k) K212193

Substantially Equivalent

Plasmapp Co,., Ltd.

FDA 510(k) clearance K212193 for Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), Substantially Equivalent on 2021-10-22. 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
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