Cleared Traditional

VOLU-SOL GILLS EA

K822035 · Volu Sol Medical Industries · Pathology
Aug 1982
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K822035 is an FDA 510(k) clearance for the VOLU-SOL GILLS EA, 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 August 3, 1982, 22 days after receiving the submission on July 12, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K822035 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1982
Decision Date August 03, 1982
Days to Decision 22 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