Cleared Traditional

ANOMALOSCOPE QUADRANT TEST-6

K913962 · Lkc Technologies, Inc. · Ophthalmic

Oct 1991

Decision

48d

Days

Class 1

Risk

About This 510(k) Submission

K913962 is an FDA 510(k) clearance for the ANOMALOSCOPE QUADRANT TEST-6, a Anomaloscope (Class I — General Controls, product code HIW), submitted by Lkc Technologies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on October 23, 1991, 48 days after receiving the submission on September 5, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1070.

Submission Details

510(k) Number	K913962 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 1991
Decision Date	October 23, 1991
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement