Cleared Traditional

VOLU-SOL HARRIS HEMATOXYLIN

K800324 · Volu Sol Medical Industries · Pathology
Feb 1980
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K800324 is an FDA 510(k) clearance for the VOLU-SOL HARRIS HEMATOXYLIN, a Hematoxylin Harris's (Class I — General Controls, product code HYK), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on February 22, 1980, 10 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 K800324 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1980
Decision Date February 22, 1980
Days to Decision 10 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HYK — Hematoxylin Harris's
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850