Clearance Summary
DYE CURVE EVALUATOR received FDA 510(k) clearance under submission number K792135, sponsored by Sci-Pro, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-01-11.
- Submission: K792135
- Applicant / Sponsor: Sci-Pro, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 1980-01-11
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.