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FDA 510(k)

Carolina Liquid Chemistries 可卡因和可卡因代谢物测试系统 (COCM)

K号: K163570 · 2017-08-15

申请人Carolina Liquid Chemistries Corporation
决定日期2017-08-15
产品代码DIO
咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corporation. It received FDA 510(k) clearance on 2017-08-15 under 510(k) number K163570. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)?

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is a medical device that received FDA 510(k) clearance on 2017-08-15. The listed applicant is Carolina Liquid Chemistries Corporation. The 510(k) number is K163570.

When did Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) receive FDA 510(k) clearance?

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) received FDA 510(k) clearance on 2017-08-15, under 510(k) number K163570.

Who is the listed applicant for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)?

The FDA 510(k) record lists Carolina Liquid Chemistries Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)?

The FDA product code for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is DIO.

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：DIO）

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。

K213211Carolina Liquid Chemistries 可卡因和可卡因代谢物酶免疫测定 (COCM) 测试系统Carolina Liquid Chemistries Corp.K211973DRI 可卡因代谢物检测Microgenics CorporationK191638Pointe科学可卡因代谢物酶免疫测定Medtest DXK181499DRI 可卡因代谢物检测Microgenics CorporationK170293Emit II Plus 可卡因代谢物检测Siemens Healthcare Diagnostics, Inc.K162395MP DOA-10 面板测试杯，MP DOA-11 面板测试杯Mp Biomedicals, LLC

官方来源

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