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)— 510(k) K231169

Substantially Equivalent

Plasmapp Co,., Ltd.

FDA 510(k) clearance K231169 for 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), Substantially Equivalent on 2023-05-25. Applicant: Plasmapp Co,., Ltd..

Clearance details

Applicant: Plasmapp Co,., Ltd.
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2023-04-25
Decision date: 2023-05-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MLR

product code MLR

Malfunction: 805
Total: 805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.