Cleared Traditional

HEMATOXYLIN I

K821533 · Volu Sol Medical Industries · Pathology
Jun 1982
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K821533 is an FDA 510(k) clearance for the HEMATOXYLIN I, a Hematoxylin (Class I — General Controls, product code HYJ), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on June 10, 1982, 20 days after receiving the submission on May 21, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K821533 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1982
Decision Date June 10, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HYJ — Hematoxylin
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850