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FDA 510(k)

Cepheid Xpert SA 鼻腔完整 Control Panel

K号: K191168 · 2019-06-25

申请人Microbiologics, Inc.
决定日期2019-06-25
产品代码PMN
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决定实质等同

器械摘要

Cepheid Xpert SA Nasal Complete Control Panel is the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2019-06-25 under 510(k) number K191168. 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 Cepheid Xpert SA Nasal Complete Control Panel?

Cepheid Xpert SA Nasal Complete Control Panel is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Microbiologics, Inc.. The 510(k) number is K191168.

When did Cepheid Xpert SA Nasal Complete Control Panel receive FDA 510(k) clearance?

Cepheid Xpert SA Nasal Complete Control Panel received FDA 510(k) clearance on 2019-06-25, under 510(k) number K191168.

Who is the listed applicant for Cepheid Xpert SA Nasal Complete Control Panel?

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

What is the FDA product code for Cepheid Xpert SA Nasal Complete Control Panel?

The FDA product code for Cepheid Xpert SA Nasal Complete Control Panel 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Microbiologics, 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。

K190086Cepheid Xpert 呼吸道 Control PanelK191172Cepheid Xpert MRSA NxG Control PanelK190223Cepheid Xpert CT/NG Control PanelK190463Cepheid Xpert C. difficile/Epi Control PanelK182472Cepheid Xpert GBS LB Control PanelK181683BD MAX CT/GC/TV 20-Day 质量控制板

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

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