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FDA 510(k)

ARK 氧卡巴胆碱代谢物检测，ARK 氧卡巴胆碱代谢物校准器，ARK 氧卡巴胆碱代谢物对照

K号: K153596 · 2016-08-09

申请人Ark Diagnostics, Inc.
决定日期2016-08-09
产品代码POX
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决定实质等同

器械摘要

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K153596. The device is classified under product code POX. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K153596.

When did ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control receive FDA 510(k) clearance?

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control received FDA 510(k) clearance on 2016-08-09, under 510(k) number K153596.

Who is the listed applicant for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

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

What is the FDA product code for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

The FDA product code for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is POX.

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Ark Diagnostics, 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。

K232522ARK 左乙拉西坦II测定法K232017ARK 甲氨蝶呤II测定法K231752ARK 氢可酮测定法K201089ARK 拉考沙胺测定法K200197ARK 芬太尼II测定法K182280ARK 曲马多检测

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官方来源

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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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