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FDA 510(k)

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

K号: K181436 · 2018-06-22

申请人SEKISUI Diagnostics, LLC
决定日期2018-06-22
产品代码KTN
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决定实质等同

器械摘要

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K181436. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K181436.

When did OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test receive FDA 510(k) clearance?

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test received FDA 510(k) clearance on 2018-06-22, under 510(k) number K181436.

Who is the listed applicant for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

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

What is the FDA product code for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

The FDA product code for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is KTN.

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SEKISUI Diagnostics, 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。

K241188Acucy®流感A&B测试与Acucy® 2系统K192719Osom Ultra Plus 流感A&B测试套件K182001Acucy流感A&B测试与Acucy系统

官方来源

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