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FDA 510(k)

Ensol EnTM 样本收集和运输系统

K号: K220908 · 2024-08-29

决定日期2024-08-29
产品代码JSM
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决定实质等同

器械摘要

Ensol EnTM Specimen Collection and Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Ensol Biosciences, Inc.. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K220908. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ensol EnTM Specimen Collection and Transport System?

Ensol EnTM Specimen Collection and Transport System is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Ensol Biosciences, Inc.. The 510(k) number is K220908.

When did Ensol EnTM Specimen Collection and Transport System receive FDA 510(k) clearance?

Ensol EnTM Specimen Collection and Transport System received FDA 510(k) clearance on 2024-08-29, under 510(k) number K220908.

Who is the listed applicant for Ensol EnTM Specimen Collection and Transport System?

The FDA 510(k) record lists Ensol Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ensol EnTM Specimen Collection and Transport System?

The FDA product code for Ensol EnTM Specimen Collection and Transport System is JSM.

相关临床试验

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。

相关器械(代码:JSM)

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。

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