Clearance Summary
I-STAT CREATINE KINASE MB (CK-MB) received FDA 510(k) clearance under submission number K051433, sponsored by I-Stat Corporation. 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 2005-12-15.
- Submission: K051433
- Applicant / Sponsor: I-Stat Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2005-12-15
Classification & Regulation
This clearance is catalogued under FDA product code MYT and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.