FDA 510(k)

AllTest 尿路感染测试

K号: K252607 · 2025-10-30

决定日期2025-10-30

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

AllTest Urinary Tract Infection Test is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K252607. 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 AllTest Urinary Tract Infection Test?

AllTest Urinary Tract Infection Test is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K252607.

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

AllTest Urinary Tract Infection Test received FDA 510(k) clearance on 2025-10-30, under 510(k) number K252607.

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

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

What is the FDA product code for AllTest Urinary Tract Infection Test?

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

列明Hangzhou AllTest Biotech 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。

K260342AllTest Strep A Rapid Test K251053Shinetell PlusTM 数字型早孕测试 K242576AllTest 病毒运输培养基 K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

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官方来源

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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。