Cleared Traditional

PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15

K873911 · Richmond Products, Inc. · Ophthalmic
Dec 1987
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K873911 is an FDA 510(k) clearance for the PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15, a Tester, Color Vision (Class I — General Controls, product code HIT), submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on December 2, 1987, 68 days after receiving the submission on September 25, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1170.

Submission Details

510(k) Number K873911 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1987
Decision Date December 02, 1987
Days to Decision 68 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