Cleared Traditional

VOLU-SOL URINARY DICHROME STAIN

K801143 · Volu Sol Medical Industries · Pathology
May 1980
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K801143 is an FDA 510(k) clearance for the VOLU-SOL URINARY DICHROME STAIN, a Alcian Blue (Class I — General Controls, product code IDA), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980, 12 days after receiving the submission on May 18, 1980. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K801143 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1980
Decision Date May 30, 1980
Days to Decision 12 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IDA — Alcian Blue
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850