Cleared Traditional

VOLU-SOL EOSIN Y STAIN

K800942 · Volu Sol Medical Industries · Hematology
May 1980
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K800942 is an FDA 510(k) clearance for the VOLU-SOL EOSIN Y STAIN, a Eosin Y (Class I — General Controls, product code HYB), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980, 16 days after receiving the submission on April 22, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K800942 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1980
Decision Date May 08, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code HYB — Eosin Y
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850