Cleared Traditional

RABBIT KIDNEY CELLS

K841666 · Viromed Laboratories, Inc. · Pathology
May 1984
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K841666 is an FDA 510(k) clearance for the RABBIT KIDNEY 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 May 7, 1984, 14 days after receiving the submission on April 23, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K841666 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1984
Decision Date May 07, 1984
Days to Decision 14 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