肌酸激酶
K 號：K160570 · 2016-05-25
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器材摘要
Creatine Kinase is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K160570. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Creatine Kinase?
Creatine Kinase is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K160570.
When did Creatine Kinase receive FDA 510(k) clearance?
Creatine Kinase received FDA 510(k) clearance on 2016-05-25, under 510(k) number K160570.
Who is the listed applicant for Creatine Kinase?
The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Creatine Kinase?
The FDA product code for Creatine Kinase is JHS.
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其他以 Roche Diagnostics Operations (Rdo) 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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