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FDA 510(k)

MDx-Chex 用于 BC-GP

K号: K231221 · 2023-07-27

申请人Streck
决定日期2023-07-27
产品代码PMN
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决定实质等同

器械摘要

MDx-Chex for BC-GP is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2023-07-27 under 510(k) number K231221. 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 MDx-Chex for BC-GP?

MDx-Chex for BC-GP is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is Streck. The 510(k) number is K231221.

When did MDx-Chex for BC-GP receive FDA 510(k) clearance?

MDx-Chex for BC-GP received FDA 510(k) clearance on 2023-07-27, under 510(k) number K231221.

Who is the listed applicant for MDx-Chex for BC-GP?

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

What is the FDA product code for MDx-Chex for BC-GP?

The FDA product code for MDx-Chex for BC-GP is PMN.

列明Streck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。

K254166MDx-Chex 用于 BCNK231223MDx-Chex 用于 BC-GNK170091UA-Cellular 完整版K160585XN 医疗设备K160590XN CHECKK160588XN CHECK BF

查看所有 8 个设备 →

相关器械（代码：PMN）

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。

K261475BIOFIRE® FILMARRAY® 热带发热检测控制试剂盒Biofire Defense, LLCK260577FilmArray TF 控制板 M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex 用于 BCPStreck, LLCK254166MDx-Chex 用于 BCNStreckK254167MDx-Chex 用于 BCYStreck, LLCK251526FilmArray 胃肠道控制面板 M238Maine Molecular Quality Controls, Inc.

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。

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