FDA 510(k)

BioFire JI 控制面板 M420

K号: K203680 · 2022-07-22

申请人Maine Molecular Quality Controls, Inc.

决定日期2022-07-22

产品代码PMN

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决定实质等同

器械摘要

BioFire JI Control Panel M420 is the device name listed in this FDA 510(k) record. The listed applicant is Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K203680. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioFire JI Control Panel M420?

BioFire JI Control Panel M420 is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K203680.

When did BioFire JI Control Panel M420 receive FDA 510(k) clearance?

BioFire JI Control Panel M420 received FDA 510(k) clearance on 2022-07-22, under 510(k) number K203680.

Who is the listed applicant for BioFire JI Control Panel M420?

The FDA 510(k) record lists Maine Molecular Quality Controls, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioFire JI Control Panel M420?

The FDA product code for BioFire JI Control Panel M420 is PMN.

列明Maine Molecular Quality Controls, Inc.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。

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