Cleared Traditional

HUMAN LUNG CARCINOMA CELLS (A549)

K861373 · Viromed Laboratories, Inc. · Pathology
Apr 1986
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K861373 is an FDA 510(k) clearance for the HUMAN LUNG CARCINOMA CELLS (A549), 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 April 18, 1986, 7 days after receiving the submission on April 11, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K861373 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1986
Decision Date April 18, 1986
Days to Decision 7 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