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FDA 510(k)

TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM

K-Number: K911734 · 1991-11-07

ApplicantNorthland Cataract & Eye Care Clinic
Decision Date1991-11-07
Product CodeKYD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Northland Cataract & Eye Care Clinic. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K911734. The device is classified under product code KYD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM?

TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Northland Cataract & Eye Care Clinic. The 510(k) number is K911734.

When did TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM receive FDA 510(k) clearance?

TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM received FDA 510(k) clearance on 1991-11-07, under 510(k) number K911734.

Who is the listed applicant for TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM?

The FDA 510(k) record lists Northland Cataract & Eye Care Clinic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM?

The FDA product code for TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM is KYD.

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Related Devices (Code: KYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881515TEAR VOLUME TESTSVisionex, Inc.K832181SNO STRIPS STERILE TEARFLOW TEST STRIPSmith & Nephew, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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