系統，測試，HER-2/NEU，核酸或血清
PMA 核准號：P040005 · 2017-04-12
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決定日期2017-04-12
PMA 編號P040005
產品代碼MVD
器械分類3 類
醫療專科U
諮詢委員會PA
器材摘要
SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd.. It received FDA 510(k) clearance on 2017-04-12. The device is classified under product code MVD. It was reviewed by the PA advisory panel.
常見問題
What is the SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?
SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd..
When did SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM receive FDA 510(k) clearance?
The clearance date for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM can be found in the official FDA records.
Who is the listed applicant for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?
The FDA 510(k) record lists Agilent Technologies Singapore (International) Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?
The FDA product code for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is MVD.
相關臨床試驗
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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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