Cleared Traditional

CLEARIUM, MOUNTING MEDIUM

K830659 · Surgipath Medical Industries, Inc. · Pathology

Mar 1983

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K830659 is an FDA 510(k) clearance for the CLEARIUM, MOUNTING MEDIUM, a Media, Mounting, Oil Soluble (Class I — General Controls, product code KEP), submitted by Surgipath Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983, 15 days after receiving the submission on March 2, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K830659 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 1983
Decision Date	March 17, 1983
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—