FDA 510(k)

AllTest 尿路感染檢測試劑

K 號：K252607 · 2025-10-30

決定日期2025-10-30

產品代碼JMT

諮詢委員會CH

決定相當於

器材摘要

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.

常見問題

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.

其他以 Hangzhou AllTest Biotech Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：JMT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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