Cleared Traditional

COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM

K042970 · Copan Diagnostics, Inc. · Microbiology
Dec 2004
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K042970 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 Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on December 7, 2004, 40 days after receiving the submission on October 28, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K042970 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2004
Decision Date December 07, 2004
Days to Decision 40 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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