Clearance Summary
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... received FDA 510(k) clearance under submission number K111650, sponsored by Immunodiagnostic Systems , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2011-09-06.
- Submission: K111650
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2011-09-06
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.