Clearance Summary
TIP & MEMBRANE ASSEMBLY received FDA 510(k) clearance under submission number K921443, 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 1993-06-22.
- Submission: K921443
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 1993-06-22
Classification & Regulation
This clearance is catalogued under FDA product code HKX and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.