FDA 510(k)

SAFECARE尿液测试安非他命，SAFECARE尿液测试可卡因，SAFECARE尿液测试大麻

K号: K153646 · 2016-03-18

申请人Safecare Biotech (Hangzhou) Co., Ltd.

决定日期2016-03-18

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

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is the device name listed in this FDA 510(k) record. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K153646. 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 SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K153646.

When did SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana receive FDA 510(k) clearance?

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana received FDA 510(k) clearance on 2016-03-18, under 510(k) number K153646.

Who is the listed applicant for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

The FDA 510(k) record lists Safecare Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

The FDA product code for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is DIO.

列明Safecare Biotech (Hangzhou) 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。

K242767Safecare 尿路感染测试 K240654SAFECARE芬太尼尿液测试条；SAFECARE FYL尿液测试条 K202453SAFECARE多药物尿液测试杯，SAFECARE多药物尿液测试滴卡 K200133人绒毛膜促性腺激素尿液测试条，人绒毛膜促性腺激素尿液测试卡，人绒毛膜促性腺激素尿液测试中段 K201120SAFECARE多药物尿液测试杯，SAFECARE多药物尿液测试滴卡 K191924SAFECARE® THC尿液条测试

查看所有 9 个设备 →

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 Corporation K191638Pointe科学可卡因代谢物酶免疫测定Medtest DX K181499DRI 可卡因代谢物检测Microgenics Corporation K170293Emit II Plus 可卡因代谢物检测Siemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries 可卡因和可卡因代谢物测试系统 (COCM)Carolina Liquid Chemistries Corporation

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。