Clearance Summary
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER received FDA 510(k) clearance under submission number K062751, sponsored by Quantimetrix Corp.. 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 2006-10-03.
- Submission: K062751
- Applicant / Sponsor: Quantimetrix Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2006-10-03
Classification & Regulation
This clearance is catalogued under FDA product code JJT and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.