Cleared Traditional

VOLU-SOL SINGLE DIFFERENTIAL STAIN

K822128 · Volu Sol Medical Industries · Pathology
Aug 1982
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K822128 is an FDA 510(k) clearance for the VOLU-SOL SINGLE DIFFERENTIAL STAIN, a Biebrich Scarlet (Class I — General Controls, product code ICN), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on August 5, 1982, 17 days after receiving the submission on July 19, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K822128 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1982
Decision Date August 05, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code ICN — Biebrich Scarlet
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850