Clearance Summary
NANO-CHECK AMI CTNI CARDIAC MARKER TEST received FDA 510(k) clearance under submission number K102131, sponsored by Nano-Ditech Corporation. 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 2010-10-20.
- Submission: K102131
- Applicant / Sponsor: Nano-Ditech Corporation
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2010-10-20
Classification & Regulation
This clearance is catalogued under FDA product code MMI and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.