Cleared Traditional

ACRYTOL, MOUNTING MEDIUM

K810323 · Surgipath · Pathology

Mar 1981

Decision

28d

Days

Class 1

Risk

About This 510(k) Submission

K810323 is an FDA 510(k) clearance for the ACRYTOL, MOUNTING MEDIUM, a Media, Mounting, Oil Soluble (Class I — General Controls, product code KEP), submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on March 6, 1981, 28 days after receiving the submission on February 6, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K810323 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 1981
Decision Date	March 06, 1981
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—