MRDx BCR-ABL 測試，MRDx BCR-ABL 測試軟體
K 號：K173492 · 2017-12-22
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器材摘要
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software is the device name listed in this FDA 510(k) record. The listed applicant is Molecularmd Corporation. It received FDA 510(k) clearance on 2017-12-22 under 510(k) number K173492. The device is classified under product code OYX. It was reviewed by the MG advisory panel. FDA Decision: Unknown.
常見問題
What is the MRDx BCR-ABL Test, MRDx BCR-ABL Test Software?
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software is a medical device that received FDA 510(k) clearance on 2017-12-22. The listed applicant is Molecularmd Corporation. The 510(k) number is K173492.
When did MRDx BCR-ABL Test, MRDx BCR-ABL Test Software receive FDA 510(k) clearance?
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software received FDA 510(k) clearance on 2017-12-22, under 510(k) number K173492.
Who is the listed applicant for MRDx BCR-ABL Test, MRDx BCR-ABL Test Software?
The FDA 510(k) record lists Molecularmd Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MRDx BCR-ABL Test, MRDx BCR-ABL Test Software?
The FDA product code for MRDx BCR-ABL Test, MRDx BCR-ABL Test Software is OYX.
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。
相關器械（代碼：OYX）
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
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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