Cleared Traditional

EOSIN Y SOLUTIN, AGUEOUS

K821574 · Sigma Chemical Co. · Pathology
Jun 1982
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K821574 is an FDA 510(k) clearance for the EOSIN Y SOLUTIN, AGUEOUS, 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 10, 1982, 14 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 K821574 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1982
Decision Date June 10, 1982
Days to Decision 14 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