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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 the device name listed in this FDA 510(k) record. The listed applicant is Copan Italia Spa. It received FDA 510(k) clearance on 2018-03-23 under 510(k) 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. The listed applicant is Copan Italia Spa. The 510(k) number is K180052.

When did UriSwab-Urine Collection, Transport and Preservation System receive FDA 510(k) clearance?

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

Who is the listed applicant for UriSwab-Urine Collection, Transport and Preservation System?

The FDA 510(k) record lists Copan Italia Spa as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Copan Italia Spa as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232565UriSponge™K232357Copan Universal Transport Medium (UTM-RT) SystemK220052Copan FecalSwab Collection, Transport and Preservation SystemK201849eNAT molecular collection and preservation medium

Related Devices (Code: JSM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceMedical Wire & Equipment Company (Bath), Ltd.K250205Babio® Virus Transport Kit (Non-inactivating)Jinan Babio Biotechnology Co., Ltd.K242576AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd.K232565UriSponge™Copan Italia SpaK220908Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc.K240235OmniTrans Transport SystemShenzhen Dakewe Bio-Engineering 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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