Clearance Summary
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) received FDA 510(k) clearance under submission number K053196, sponsored by Inverness Medical Innovations, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2005-12-16.
- Submission: K053196
- Applicant / Sponsor: Inverness Medical Innovations, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2005-12-16
Classification & Regulation
This clearance is catalogued under FDA product code NJV and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.