FDA 510(k)

BioFire RP2.1/RP2.1plus 控制面板 M441

K号: K202196 · 2021-06-24

申请人Maine Molecular Quality Controls, Inc.

决定日期2021-06-24

产品代码PMN

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

BioFire RP2.1/RP2.1plus Control Panel M441 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 2021-06-24 under 510(k) number K202196. 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 RP2.1/RP2.1plus Control Panel M441?

BioFire RP2.1/RP2.1plus Control Panel M441 is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K202196.

When did BioFire RP2.1/RP2.1plus Control Panel M441 receive FDA 510(k) clearance?

BioFire RP2.1/RP2.1plus Control Panel M441 received FDA 510(k) clearance on 2021-06-24, under 510(k) number K202196.

Who is the listed applicant for BioFire RP2.1/RP2.1plus Control Panel M441?

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 RP2.1/RP2.1plus Control Panel M441?

The FDA product code for BioFire RP2.1/RP2.1plus Control Panel M441 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。

K260577FilmArray TF 控制板 M527 K251526FilmArray 胃肠道控制面板 M238 K241289SPOTFIRE RSP 正负对照; SPOTFIRE RSP 阴性对照 K233611SPOTFIRE RSP 正负对照 (M425), SPOTFIRE RSP 阳性对照 (M42638), SPOTFIRE RSP 阴性对照 (M42738)K230868SPOTFIRE® RSP 正负对照, SPOTFIRE® RSP 阳性对照, SPOTFIRE® RSP 阴性对照 K221253SPOTFIRE RSP 阳性对照, SPOTFIRE RSP 阴性对照

查看所有 13 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。