FDA 510(k)

Safecare 尿路感染测试

K号: K242767 · 2025-01-10

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

决定日期2025-01-10

产品代码JMT

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Safecare Urinary Tract Infection 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 2025-01-10 under 510(k) number K242767. The device is classified under product code JMT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Safecare Urinary Tract Infection Test?

Safecare Urinary Tract Infection Test is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K242767.

When did Safecare Urinary Tract Infection Test receive FDA 510(k) clearance?

Safecare Urinary Tract Infection Test received FDA 510(k) clearance on 2025-01-10, under 510(k) number K242767.

Who is the listed applicant for Safecare Urinary Tract Infection 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 Urinary Tract Infection Test?

The FDA product code for Safecare Urinary Tract Infection Test is JMT.

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。

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