Cleared Traditional

UriSwab-Urine Collection, Transport and Preservation System

K180052 · Copan Italia Spa · Microbiology
Mar 2018
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K180052 is an FDA 510(k) clearance for the UriSwab-Urine 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 March 23, 2018, 74 days after receiving the submission on January 8, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K180052 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2018
Decision Date March 23, 2018
Days to Decision 74 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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