Cleared Traditional

K881369 - ADVANCE DIAGNOSTICS DISPOSABLE EYECUP
(FDA 510(k) Clearance)

K881369 · Advantage Diagnostics Corp. · Ophthalmic device

May 1988

Decision

42d

Days

—

Risk

K881369 is an FDA 510(k) clearance for the ADVANCE DIAGNOSTICS DISPOSABLE EYECUP. This device is classified as a Cup, Eye.

Submitted by Advantage Diagnostics Corp. (Tucson, US). The FDA issued a Cleared decision on May 13, 1988, 42 days after receiving the submission on April 1, 1988.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number	K881369 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 01, 1988
Decision Date	May 13, 1988
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—