FDA 510(k)

BIOEASY大麻测试浸纸卡，BIOEASY大麻测试条

K号: K192301 · 2019-09-20

申请人Shenzhen Bioeasy Biotechnology Co., Ltd.

决定日期2019-09-20

产品代码NFW

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, BIOEASY Marijuana Test Strip 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 2019-09-20 under 510(k) number K192301. The device is classified under product code NFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K192301.

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

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip received FDA 510(k) clearance on 2019-09-20, under 510(k) number K192301.

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

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, BIOEASY Marijuana Test Strip?

The FDA product code for BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is NFW.

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Rx K193480BIOEASY多药物测试杯 K192515BIOEASY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 K182530BIOEASY多药物测试杯

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。