Cleared Traditional

TRICHROME STAIN

K820634 · Volu Sol Medical Industries · Pathology
Mar 1982
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K820634 is an FDA 510(k) clearance for the TRICHROME STAIN, a Fast Green (Class I — General Controls, product code HYC), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982, 18 days after receiving the submission on March 8, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K820634 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1982
Decision Date March 26, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HYC — Fast Green
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850