Cleared Traditional

ANOMALOSCOPE PLATE TEST - 5 [APT-5]

K875026 · Lkc Technologies, Inc. · Ophthalmic
Feb 1988
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K875026 is an FDA 510(k) clearance for the ANOMALOSCOPE PLATE TEST - 5 [APT-5], a Tester, Color Vision (Class I — General Controls, product code HIT), submitted by Lkc Technologies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on February 5, 1988, 60 days after receiving the submission on December 7, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1170.

Submission Details

510(k) Number K875026 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1987
Decision Date February 05, 1988
Days to Decision 60 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HIT — Tester, Color Vision
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1170

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