FDA 510(k)

eNAT分子采集与保存介质

K号: K201849 · 2020-09-17

决定日期2020-09-17

产品代码QBD

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决定实质等同

器械摘要

eNAT molecular collection and preservation medium 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 2020-09-17 under 510(k) number K201849. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the eNAT molecular collection and preservation medium?

eNAT molecular collection and preservation medium is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Copan Italia Spa. The 510(k) number is K201849.

When did eNAT molecular collection and preservation medium receive FDA 510(k) clearance?

eNAT molecular collection and preservation medium received FDA 510(k) clearance on 2020-09-17, under 510(k) number K201849.

Who is the listed applicant for eNAT molecular collection and preservation medium?

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 eNAT molecular collection and preservation medium?

The FDA product code for eNAT molecular collection and preservation medium is QBD.

列明Copan Italia Spa为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232565UriSponge™K232357Copan Universal Transport Medium (UTM-RT) System K220052Copan FecalSwab Collection, Transport and Preservation System K180052UriSwab-Urine Collection, Transport and Preservation System

官方来源

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