Cleared Traditional

HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)

K862555 · Viromed Laboratories, Inc. · Pathology
Jul 1986
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K862555 is an FDA 510(k) clearance for the HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA), 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 10, 1986, 7 days after receiving the submission on July 3, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K862555 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1986
Decision Date July 10, 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