Cleared Traditional

Copan FecalSwab Collection, Transport and Preservation System

K220052 · Copan Italia Spa · Microbiology
Dec 2022
Decision
344d
Days
Class 1
Risk

About This 510(k) Submission

K220052 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 (Brescia, IT). The FDA issued a Cleared decision on December 16, 2022, 344 days after receiving the submission on January 6, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K220052 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 2022
Decision Date December 16, 2022
Days to Decision 344 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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