Cleared Traditional

EOSIN Y SOLUTION ALCHOLIC

K821573 · Sigma Chemical Co. · Pathology
Jun 1982
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K821573 is an FDA 510(k) clearance for the EOSIN Y SOLUTION ALCHOLIC, a Eosin Y (Class I — General Controls, product code HYB), submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1982, 13 days after receiving the submission on May 27, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K821573 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1982
Decision Date June 09, 1982
Days to Decision 13 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

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