FDA 510(k)

Healgen® URS測試條

K 號：K251800 · 2025-12-23

決定日期2025-12-23

產品代碼JMT

諮詢委員會CH

決定相當於

器材摘要

Healgen® URS Test Strips is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251800. 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 Healgen® URS Test Strips?

Healgen® URS Test Strips is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K251800.

When did Healgen® URS Test Strips receive FDA 510(k) clearance?

Healgen® URS Test Strips received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251800.

Who is the listed applicant for Healgen® URS Test Strips?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healgen® URS Test Strips?

The FDA product code for Healgen® URS Test Strips is JMT.

其他以 Healgen Scientific,, LLC 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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