Cleared Traditional

WI-38

K841806 · Viromed Laboratories, Inc. · Pathology
Jun 1984
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K841806 is an FDA 510(k) clearance for the WI-38, a Cells, Animal And Human, Cultured (Class I — General Controls, product code KIR), submitted by Viromed Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984, 37 days after receiving the submission on May 1, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K841806 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1984
Decision Date June 07, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIR — Cells, Animal And Human, Cultured
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2280