Cleared Traditional

INSTANT EOSIN-ALCOHOLIC

K880240 · Shandon, Inc. · Pathology

Mar 1988

Decision

43d

Days

Class 1

Risk

About This 510(k) Submission

K880240 is an FDA 510(k) clearance for the INSTANT EOSIN-ALCOHOLIC, a Eosin Y (Class I — General Controls, product code HYB), submitted by Shandon, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on March 3, 1988, 43 days after receiving the submission on January 20, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K880240 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 1988
Decision Date	March 03, 1988
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—