Clearance Summary
IDS-iSYS Ostase BAP received FDA 510(k) clearance under submission number K200475, sponsored by Immunodiagnostic Systems , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2020-09-30.
- Submission: K200475
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1050
- Decision date: 2020-09-30
Classification & Regulation
This clearance is catalogued under FDA product code CIN and 21 CFR 862.1050, within the Clinical Chemistry review panel as a Class II device.