Clearance Summary
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set received FDA 510(k) clearance under submission number K161831, 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 2016-11-15.
- Submission: K161831
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1825
- Decision date: 2016-11-15
Classification & Regulation
This clearance is catalogued under FDA product code MRG and 21 CFR 862.1825, within the Clinical Chemistry review panel as a Class II device.