Clearance Summary
CREATINE KINASE-MB KIT received FDA 510(k) clearance under submission number K820812, sponsored by Calbiochem-Behring Corp.. 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 1982-04-12.
- Submission: K820812
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1982-04-12
Classification & Regulation
This clearance is catalogued under FDA product code JHY and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.