FDA PMA

KIT, 神經管缺陷測試，甲胎蛋白

PMA 核准號：P010007 · 2026-09-22

決定日期2026-09-22

PMA 編號P010007

產品代碼LOK

器械分類3 類

醫療專科U

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]。

器材摘要

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-09-22. The device is classified under product code LOK. It was reviewed by the IM advisory panel.

常見問題

What is the KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Siemens Healthcare Diagnostics, Inc..

When did KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS receive FDA 510(k) clearance?

The clearance date for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS can be found in the official FDA records.

誰是KIT、TEST、ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS的登記申請人？

FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。

FDA產品代碼為KIT、TEST、ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS的是什麼？

FDA產品代碼為KIT、TEST、ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS的產品為LOK。

官方來源

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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。