Cleared Traditional

MDCK

K852394 · Viromed Laboratories, Inc. · Pathology
Jul 1985
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K852394 is an FDA 510(k) clearance for the MDCK, 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 July 12, 1985, 36 days after receiving the submission on June 6, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K852394 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1985
Decision Date July 12, 1985
Days to Decision 36 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