Clearance Summary
DIGILAB 350 THE KRAKAU PERIMETER received FDA 510(k) clearance under submission number K832175, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1983-08-16.
- Submission: K832175
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1605
- Decision date: 1983-08-16
Classification & Regulation
This clearance is catalogued under FDA product code HPT and 21 CFR 886.1605, within the Ophthalmic review panel as a Class I device.