FDA 510(k)

Copan FecalSwab Collection, Transport and Preservation System

Número K: K220052 · 2022-12-16

Data da decisão2022-12-16

Código do produtoJSM

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Copan FecalSwab 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 2022-12-16 under 510(k) number K220052. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Copan FecalSwab Collection, Transport and Preservation System?

Copan FecalSwab Collection, Transport and Preservation System is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Copan Italia Spa. The 510(k) number is K220052.

When did Copan FecalSwab Collection, Transport and Preservation System receive FDA 510(k) clearance?

Copan FecalSwab Collection, Transport and Preservation System received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220052.

Who is the listed applicant for Copan FecalSwab 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 Copan FecalSwab Collection, Transport and Preservation System?

The FDA product code for Copan FecalSwab Collection, Transport and Preservation System is JSM.

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Outros registros que listam Copan Italia Spa como candidato(a)

K232565UriSponge™K232357Copan Universal Transport Medium (UTM-RT) System K201849eNAT molecular collection and preservation medium K180052Sistema de Coleta, Transporte e Preservação de Urina UriSwab

Dispositivos Relacionados (Código: JSM)

K242976Dispositivo de Coleta e Transporte de Meio de Cultivo Líquido Cary Blair para Transwab Fecal de Fio MédicoMedical Wire & Equipment Company (Bath), Ltd.K250205Babio® Virus Transport Kit (Non-inactivating)Jinan Babio Biotechnology Co., Ltd.K242576Meio de Transporte Viral AllTestHangzhou AllTest Biotech Co., Ltd.K232565UriSponge™Copan Italia Spa K220908Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc.K240235OmniTrans Transport SystemShenzhen Dakewe Bio-Engineering Co., Ltd.

Fonte oficial

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