MDx-Chex 用于 BCP
K号: K260041 · 2026-03-27
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器械摘要
MDx-Chex for BCP is the device name listed in this FDA 510(k) record. The listed applicant is Streck, LLC. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K260041. 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 BCP?
MDx-Chex for BCP is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Streck, LLC. The 510(k) number is K260041.
When did MDx-Chex for BCP receive FDA 510(k) clearance?
MDx-Chex for BCP received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260041.
Who is the listed applicant for MDx-Chex for BCP?
The FDA 510(k) record lists Streck, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MDx-Chex for BCP?
The FDA product code for MDx-Chex for BCP is PMN.
列明Streck, LLC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。
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.K254166MDx-Chex 用于 BCNStreckK254167MDx-Chex 用于 BCYStreck, LLCK251526FilmArray 胃肠道控制面板 M238Maine Molecular Quality Controls, Inc.K241289SPOTFIRE RSP 正负对照; SPOTFIRE RSP 阴性对照Maine 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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