Clearance Summary
LIGHT-PEN SYSTEM FOR QUANTI. ANALY. received FDA 510(k) clearance under submission number K772158, sponsored by Varian Assoc., 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 1977-11-22.
- Submission: K772158
- Applicant / Sponsor: Varian Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1977-11-22
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.