Cleared Traditional

INSTANT EOSIN-AQUEOUS

K893663 · Shandon, Inc. · Pathology
Jun 1989
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K893663 is an FDA 510(k) clearance for the INSTANT EOSIN-AQUEOUS, a Eosin Y (Class I — General Controls, product code HYB), submitted by Shandon, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on June 13, 1989, 29 days after receiving the submission on May 15, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K893663 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1989
Decision Date June 13, 1989
Days to Decision 29 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