Cleared Traditional

VERO CELLS

K831680 · Viromed Laboratories, Inc. · Pathology
Jul 1983
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K831680 is an FDA 510(k) clearance for the VERO CELLS, 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 July 6, 1983, 43 days after receiving the submission on May 24, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K831680 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1983
Decision Date July 06, 1983
Days to Decision 43 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