FDA 510(k)

SAFECARE® THC尿液条测试

K号: K191924 · 2019-08-16

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

决定日期2019-08-16

产品代码NFW

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决定实质等同

器械摘要

SAFECARE® THC Urine Strip Test 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 2019-08-16 under 510(k) number K191924. 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 SAFECARE® THC Urine Strip Test?

SAFECARE® THC Urine Strip Test is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K191924.

When did SAFECARE® THC Urine Strip Test receive FDA 510(k) clearance?

SAFECARE® THC Urine Strip Test received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191924.

Who is the listed applicant for SAFECARE® THC Urine Strip Test?

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® THC Urine Strip Test?

The FDA product code for SAFECARE® THC Urine Strip Test is NFW.

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 K182654SAFECARE多药物尿液测试杯，SAFECARE多药物尿液测试滴卡

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