Clearance Summary
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET received FDA 510(k) clearance under submission number K140554, 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 2014-12-19.
- Submission: K140554
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1825
- Decision date: 2014-12-19
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.