Cleared Traditional

BUFFALO GREEN MONKEY KIDNEY CELLS

K871613 · Viromed Laboratories, Inc. · Pathology
May 1987
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K871613 is an FDA 510(k) clearance for the BUFFALO GREEN MONKEY KIDNEY CELLS, a Cells, Animal And Human, Cultured (Class I — General Controls, product code KIR), submitted by Viromed Laboratories, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 13, 1987, 19 days after receiving the submission on April 24, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K871613 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1987
Decision Date May 13, 1987
Days to Decision 19 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