Cleared Traditional

HEK

K842584 · Viromed Laboratories, Inc. · Pathology
Jul 1984
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K842584 is an FDA 510(k) clearance for the HEK, 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 27, 1984, 24 days after receiving the submission on July 3, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K842584 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1984
Decision Date July 27, 1984
Days to Decision 24 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