FDA 510(k)

SAFECARE多药物尿液测试杯，SAFECARE多药物尿液测试滴卡

K号: K181968 · 2018-08-20

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

决定日期2018-08-20

产品代码NFT

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决定实质等同

器械摘要

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card 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 2018-08-20 under 510(k) number K181968. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card is a medical device that received FDA 510(k) clearance on 2018-08-20. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K181968.

When did SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card receive FDA 510(k) clearance?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card received FDA 510(k) clearance on 2018-08-20, under 510(k) number K181968.

Who is the listed applicant for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card?

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 Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card?

The FDA product code for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card is NFT.

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：NFT）

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。

K261409BioTeke® 多药物尿液检测杯Bioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech 快速杯测试；AssureTech 多药物尿液测试杯Assure Tech., LLC K261280BioSieve多药物尿液测试板；BioSieve多药物尿液家庭测试板Vivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip多药物尿液测试板；SAFElife T-Dip多药物尿液测试板 DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest 多药物尿液杯；Webest 家庭多药物尿液杯WEBEST Biotech,, LLC K252550SAFElife T-Cup多药物尿液测试杯；SAFElife T-Cup多药物尿液测试杯 DxGuangzhou Wondfo Biotech Co., Ltd.

官方来源

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