Clearance Summary
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) received FDA 510(k) clearance under submission number K220345, sponsored by Plasmapp Co,., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-04-14.
- Submission: K220345
- Applicant / Sponsor: Plasmapp Co,., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6860
- Decision date: 2023-04-14
Classification & Regulation
This clearance is catalogued under FDA product code MLR and 21 CFR 880.6860, within the General Hospital review panel as a Class II device.