QwikCheck 化學指示標
K 號：K192445 · 2020-04-02
廣告
決定日期2020-04-02
產品代碼JOJ
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
QwikCheck Chemical Indicators is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corporation. It received FDA 510(k) clearance on 2020-04-02 under 510(k) number K192445. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the QwikCheck Chemical Indicators?
QwikCheck Chemical Indicators is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Serim Research Corporation. The 510(k) number is K192445.
When did QwikCheck Chemical Indicators receive FDA 510(k) clearance?
QwikCheck Chemical Indicators received FDA 510(k) clearance on 2020-04-02, under 510(k) number K192445.
Who is the listed applicant for QwikCheck Chemical Indicators?
The FDA 510(k) record lists Serim Research Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for QwikCheck Chemical Indicators?
The FDA product code for QwikCheck Chemical Indicators is JOJ.
相關臨床試驗
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。
其他以 Serim Research Corporation 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。
相關器械（代碼：JOJ）
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。
K2619923M™ Attest™ 蒸氣化學整合器 (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCK260181蒸汽滅菌過程指示膠帶Intertape Polymer GroupK251991安全穩定蒸氣消毒過程指示器（4012、4013、4014、4016）；安全穩定氣化過氧化氫消毒過程指示器（4211、4212、4213）Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA 測試條Serim ResearchK251048Rapicide PA 高級消毒試紙 模型參考編號 = ML02-0118STERIS CorporationK243876驗證蒸汽整合指示器STERIS Corporation
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。
廣告