FilmArray TF 控制板 M527
K号: K260577 · 2026-05-19
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决定日期2026-05-19
产品代码PMN
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器械摘要
FilmArray TF Control Panel M527 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 2026-05-19 under 510(k) number K260577. 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 FilmArray TF Control Panel M527?
FilmArray TF Control Panel M527 is a medical device that received FDA 510(k) clearance on 2026-05-19. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K260577.
When did FilmArray TF Control Panel M527 receive FDA 510(k) clearance?
FilmArray TF Control Panel M527 received FDA 510(k) clearance on 2026-05-19, under 510(k) number K260577.
Who is the listed applicant for FilmArray TF Control Panel M527?
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 FilmArray TF Control Panel M527?
The FDA product code for FilmArray TF Control Panel M527 is PMN.
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。
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。
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, LLCK260041MDx-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.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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