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FDA 510(k)

BIOEASY大麻测试浸纸卡40，BIOEASY大麻测试浸纸卡20，BIOEASY大麻测试条40，BIOEASY大麻测试条20

K号: K192515 · 2019-10-11

申请人Shenzhen Bioeasy Biotechnology Co., Ltd.
决定日期2019-10-11
产品代码LDJ
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

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K192515. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20?

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K192515.

When did BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 receive FDA 510(k) clearance?

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 received FDA 510(k) clearance on 2019-10-11, under 510(k) number K192515.

Who is the listed applicant for BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20?

The FDA 510(k) record lists Shenzhen Bioeasy Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20?

The FDA product code for BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 is LDJ.

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Shenzhen Bioeasy Biotechnology Co., Ltd.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。

K230238BIOEASY® U-Catch MAX多药物测试杯，BIOEASY® U-Catch MAX多药物测试杯RxK193480BIOEASY多药物测试杯K192301BIOEASY大麻测试浸纸卡，BIOEASY大麻测试条K182530BIOEASY多药物测试杯

相关器械（代码：LDJ）

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。

K232732Rapid 毒品（THC）测试条 20，Rapid 毒品（THC）测试浸卡 20，Rapid 毒品（THC）测试条 50，Rapid 毒品（THC）测试浸卡 50Co-Innovation Biotech Co., Ltd.K232604LYHER® 尿液大麻（THC）测试套件（条），LYHER® 尿液大麻（THC）测试套件（卡式）Hangzhou Laihe Biotech Co., Ltd.K223162Healgen® 准确度 口腔液体药物测试，Healgen® 准确度 口腔液体药物测试 COTHealgen Scientific,, LLCK153741CLUNGENE 甲基安非他命测试，CLUNGENE 吗啡测试，CLUNGENE 大麻测试Hangzhou Clongene Biotech Co., Ltd.

官方来源

在 FDA 数据库中查看 →

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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