Cleared Traditional

VOLU-SOL EA-50 STAIN

K800322 · Volu Sol Medical Industries · Pathology
Feb 1980
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K800322 is an FDA 510(k) clearance for the VOLU-SOL EA-50 STAIN, a Stain, Papanicolau (Class I — General Controls, product code HZJ), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980, 14 days after receiving the submission on February 12, 1980. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K800322 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1980
Decision Date February 26, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HZJ — Stain, Papanicolau
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850