GenetiSure Dx 新生兒檢測試劑
K 號：K163367 · 2017-08-11
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決定日期2017-08-11
產品代碼PFX
諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。
決定相當於
器材摘要
GenetiSure Dx Postnatal Assay is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies, Inc.. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K163367. The device is classified under product code PFX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GenetiSure Dx Postnatal Assay?
GenetiSure Dx Postnatal Assay is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Agilent Technologies, Inc.. The 510(k) number is K163367.
When did GenetiSure Dx Postnatal Assay receive FDA 510(k) clearance?
GenetiSure Dx Postnatal Assay received FDA 510(k) clearance on 2017-08-11, under 510(k) number K163367.
Who is the listed applicant for GenetiSure Dx Postnatal Assay?
The FDA 510(k) record lists Agilent Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GenetiSure Dx Postnatal Assay?
The FDA product code for GenetiSure Dx Postnatal Assay is PFX.
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。
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