Clearance Summary
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers received FDA 510(k) clearance under submission number K142994, 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 2015-04-21.
- Submission: K142994
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1045
- Decision date: 2015-04-21
Classification & Regulation
This clearance is catalogued under FDA product code CJM and 21 CFR 862.1045, within the Clinical Chemistry review panel as a Class II device.