Clearance Summary
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM received FDA 510(k) clearance under submission number K911734, sponsored by Northland Cataract & Eye Care Clinic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1991-11-07.
- Submission: K911734
- Applicant / Sponsor: Northland Cataract & Eye Care Clinic
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1800
- Decision date: 1991-11-07
Classification & Regulation
This clearance is catalogued under FDA product code KYD and 21 CFR 886.1800, within the Ophthalmic review panel as a Class I device.