Cleared Traditional

PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU

K821019 · Microbiological Research Corp. · Pathology
Apr 1982
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K821019 is an FDA 510(k) clearance for the PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU, a Mounting Media (Class I — General Controls, product code LEB), submitted by Microbiological Research Corp. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982, 14 days after receiving the submission on April 12, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K821019 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1982
Decision Date April 26, 1982
Days to Decision 14 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