Clearance Summary
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS received FDA 510(k) clearance under submission number K123763, 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 2013-12-24.
- Submission: K123763
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1085
- Decision date: 2013-12-24
Classification & Regulation
This clearance is catalogued under FDA product code CIB and 21 CFR 862.1085, within the Clinical Chemistry review panel as a Class II device.