Cleared Traditional

AFRICAN GREEN SV 5/SV 40

K843252 · Viromed Laboratories, Inc. · Pathology
Sep 1984
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K843252 is an FDA 510(k) clearance for the AFRICAN GREEN SV 5/SV 40, 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 September 6, 1984, 17 days after receiving the submission on August 20, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K843252 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1984
Decision Date September 06, 1984
Days to Decision 17 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