Cleared Traditional

COLOR VISION TESTERS

K844365 · Luneau Laboratories · Ophthalmic
Jan 1985
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K844365 is an FDA 510(k) clearance for the COLOR VISION TESTERS, a Tester, Color Vision (Class I — General Controls, product code HIT), submitted by Luneau Laboratories (Walker, US). The FDA issued a Cleared decision on January 2, 1985, 50 days after receiving the submission on November 13, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1170.

Submission Details

510(k) Number K844365 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1984
Decision Date January 02, 1985
Days to Decision 50 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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