Clearance Summary
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH received FDA 510(k) clearance under submission number K050889, sponsored by Crs Medical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-08-26.
- Submission: K050889
- Applicant / Sponsor: Crs Medical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2005-08-26
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.