GUARDIAN™ 快速測試餘氯 (5212)
K 號：K253863 · 2026-03-17
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器材摘要
GUARDIAN™ Quick Dip Residual Chlorine (5212) is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K253863. The device is classified under product code FKJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GUARDIAN™ Quick Dip Residual Chlorine (5212)?
GUARDIAN™ Quick Dip Residual Chlorine (5212) is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Serim Research. The 510(k) number is K253863.
When did GUARDIAN™ Quick Dip Residual Chlorine (5212) receive FDA 510(k) clearance?
GUARDIAN™ Quick Dip Residual Chlorine (5212) received FDA 510(k) clearance on 2026-03-17, under 510(k) number K253863.
Who is the listed applicant for GUARDIAN™ Quick Dip Residual Chlorine (5212)?
The FDA 510(k) record lists Serim Research as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GUARDIAN™ Quick Dip Residual Chlorine (5212)?
The FDA product code for GUARDIAN™ Quick Dip Residual Chlorine (5212) is FKJ.
相關臨床試驗
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其他以 Serim Research 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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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