Cleared Traditional

Copan Universal Transport Medium (UTM-RT) System

K232357 · Copan Italia Spa · Microbiology
Apr 2024
Decision
262d
Days
Class 1
Risk

About This 510(k) Submission

K232357 is an FDA 510(k) clearance for the Copan Universal Transport Medium (UTM-RT) 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 April 25, 2024, 262 days after receiving the submission on August 7, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K232357 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2023
Decision Date April 25, 2024
Days to Decision 262 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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