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FDA 510(k)

Remel Spectra ESBL

K号: K162620 · 2017-05-01

申请人Remel, Inc.
决定日期2017-05-01
产品代码JSO
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决定实质等同

器械摘要

Remel Spectra ESBL is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K162620. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Remel Spectra ESBL?

Remel Spectra ESBL is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Remel, Inc.. The 510(k) number is K162620.

When did Remel Spectra ESBL receive FDA 510(k) clearance?

Remel Spectra ESBL received FDA 510(k) clearance on 2017-05-01, under 510(k) number K162620.

Who is the listed applicant for Remel Spectra ESBL?

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

What is the FDA product code for Remel Spectra ESBL?

The FDA product code for Remel Spectra ESBL is JSO.

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：JSO）

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。

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA 琼脂 (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK160512HardyCHROM ESBLHardy DiagnosticsK162076chromID 耐甲氧西林金黄色葡萄球菌检测装置bioMerieux, Inc.K151688chromID 耐甲氧西林金黄色葡萄球菌检测装置bioMerieux, Inc.

官方来源

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