Cleared Traditional

REFRAX MOUNTING MEDIUM

K842986 · Anatech, Ltd. · Pathology
Aug 1984
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K842986 is an FDA 510(k) clearance for the REFRAX MOUNTING MEDIUM, a Mounting Media (Class I — General Controls, product code LEB), submitted by Anatech, Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1984, 22 days after receiving the submission on July 30, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K842986 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1984
Decision Date August 21, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary

Device Classification

Product Code LEB — Mounting Media
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010