體細胞基因突變檢測系統
PMA 核准號：P120014 · 2021-12-20
廣告
器材摘要
Somatic gene mutation detection system is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2021-12-20. The device is classified under product code OWD. It was reviewed by the PA advisory panel.
常見問題
What is the Somatic gene mutation detection system?
Somatic gene mutation detection system is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is bioMerieux, Inc..
When did Somatic gene mutation detection system receive FDA 510(k) clearance?
The clearance date for Somatic gene mutation detection system can be found in the official FDA records.
Who is the listed applicant for Somatic gene mutation detection system?
The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Somatic gene mutation detection system?
The FDA product code for Somatic gene mutation detection system is OWD.
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。
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