Cleared Traditional

EOSIN Y

K811826 · Surgipath · Pathology
Jul 1981
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K811826 is an FDA 510(k) clearance for the EOSIN Y, a Eosin Y (Class I — General Controls, product code HYB), submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981, 11 days after receiving the submission on June 29, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K811826 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1981
Decision Date July 10, 1981
Days to Decision 11 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