Cleared Traditional

COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

K142094 · Copan Italia Spa · Microbiology
Apr 2015
Decision
252d
Days
Class 1
Risk

About This 510(k) Submission

K142094 is an FDA 510(k) clearance for the COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Copan Italia Spa (Marlborough, US). The FDA issued a Cleared decision on April 10, 2015, 252 days after receiving the submission on August 1, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K142094 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2014
Decision Date April 10, 2015
Days to Decision 252 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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