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FDA 510(k)

APAS 独立型带 IC 酶联荧光 MRSA BD 分析模块；APAS 独立型带 IC 酶联荧光 MRSA TFS/S 分析模块

K号: K200839 · 2021-10-28

申请人Clever Culture Systems
决定日期2021-10-28
产品代码QQY
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决定实质等同

器械摘要

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is the device name listed in this FDA 510(k) record. The listed applicant is Clever Culture Systems. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K200839. The device is classified under product code QQY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Clever Culture Systems. The 510(k) number is K200839.

When did APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module receive FDA 510(k) clearance?

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module received FDA 510(k) clearance on 2021-10-28, under 510(k) number K200839.

Who is the listed applicant for APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

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

What is the FDA product code for APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

The FDA product code for APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is QQY.

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

相关器械（代码：QQY）

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。

K213280BD Kiestra 耐甲氧西林金黄色葡萄球菌 (MRSA) 应用, BD Kiestra MRSA AppBd Kiestra B.V.

官方来源

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