FDA 510(k)

SAFECARE芬太尼尿液测试条；SAFECARE FYL尿液测试条

K号: K240654 · 2024-04-10

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

决定日期2024-04-10

产品代码NGL

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决定实质等同

器械摘要

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette 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 2024-04-10 under 510(k) number K240654. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K240654.

When did SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette receive FDA 510(k) clearance?

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette received FDA 510(k) clearance on 2024-04-10, under 510(k) number K240654.

Who is the listed applicant for SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

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 Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

The FDA product code for SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is NGL.

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

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相关器械（代码：NGL）

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。

K253567Healgen 准确尿液药物筛查条；Healgen 准确家庭尿液药物测试条Healgen Scientific,, LLC K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.K250067Dochek®多药物尿液测试杯；Dochek®多药物尿液测试杯ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek®芬太尼尿液测试条，Dochek®芬太尼尿液测试条加强版，Dochek®芬太尼尿液测试卡，Dochek®芬太尼尿液测试卡加强版，Dochek®芬太尼尿液测试杯和Dochek®芬太尼尿液测试杯加强版Guangzhou Decheng Biotechnology Co., Ltd.K243365Healgen 准确多药物尿液药物筛查杯；Healgen 准确家庭多药物尿液测试杯Healgen Scientific,, LLC K243064ETERBIO芬太尼/诺芬太尼快速测试（胶体金）；ETERBIO芬太尼/诺芬太尼家用测试Eterbio, Inc.

官方来源

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