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FDA 510(k)

UriSwab-Urine Collection, Transport and Preservation System

K-Number: K180052 · 2018-03-23

ApplicantCopan Italia Spa
Decision Date2018-03-23
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

UriSwab-Urine Collection, Transport and Preservation System is a medical device manufactured by Copan Italia Spa. It received FDA 510(k) clearance on 2018-03-23 under approval number K180052. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UriSwab-Urine Collection, Transport and Preservation System?

UriSwab-Urine Collection, Transport and Preservation System is a medical device that received FDA 510(k) clearance on 2018-03-23. It is manufactured by Copan Italia Spa. The 510(k) number is K180052.

When was UriSwab-Urine Collection, Transport and Preservation System approved by the FDA?

UriSwab-Urine Collection, Transport and Preservation System received FDA 510(k) clearance on 2018-03-23, under approval number K180052.

What company makes UriSwab-Urine Collection, Transport and Preservation System?

UriSwab-Urine Collection, Transport and Preservation System is manufactured by Copan Italia Spa.

What is the FDA product code for UriSwab-Urine Collection, Transport and Preservation System?

The FDA product code for UriSwab-Urine Collection, Transport and Preservation System is JSM.

Related Clinical Trials

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Other Devices by Copan Italia Spa

K201849eNAT molecular collection and preservation medium K220052Copan FecalSwab Collection, Transport and Preservation System K232565UriSponge™ K232357Copan Universal Transport Medium (UTM-RT) System

Related Devices (Code: JSM)

K162284Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC K160082Puritan Opti-Tranz Cary-Blair Collection and Transport SystemPuritan Medical Products, LLC K163436Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. K201674Cultura Collection and Transport SystemMerit Medical Systems, Inc. K220052Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa K220739Disposable Urine Collection TubeZhejiang Gongdong Medical Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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