Clearance Summary
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN received FDA 510(k) clearance under submission number K050975, sponsored by Nano-Ditech Co.. 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 2006-03-02.
- Submission: K050975
- Applicant / Sponsor: Nano-Ditech Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2006-03-02
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.