Cleared Traditional

MACLEAN-FOGG, DISPOS-INOCULA-LOOPS

K842057 · Polymer Technology Corp. · Microbiology
Jun 1984
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K842057 is an FDA 510(k) clearance for the MACLEAN-FOGG, DISPOS-INOCULA-LOOPS, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Polymer Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984, 16 days after receiving the submission on May 22, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K842057 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1984
Decision Date June 07, 1984
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LIB — Device, General Purpose, Microbiology, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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