FDA PMA

酵素免疫分析，胎兒膠原蛋白

PMA 核准號：P920048 · 2026-08-26

決定日期2026-08-26

PMA 編號P920048

產品代碼LKV

器械分類3 類

醫療專科U

諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯：本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。

器材摘要

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2026-08-26. The device is classified under product code LKV. It was reviewed by the TX advisory panel.

常見問題

What is the ENZYME IMMUNOASSAY, FETAL FIBRONECTIN?

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Hologic, Inc..

When did ENZYME IMMUNOASSAY, FETAL FIBRONECTIN receive FDA 510(k) clearance?

The clearance date for ENZYME IMMUNOASSAY, FETAL FIBRONECTIN can be found in the official FDA records.

誰是ENZYME IMMUNOASSAY, FETAL FIBRONECTIN的列名申請人？

FDA 510(k) 記錄將霍洛基克公司（Hologic, Inc.）列為申請人。這並不單獨確立設備製造商。

FDA產品代碼是什麼？ENZYME IMMUNOASSAY, FETAL FIBRONECTIN？

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN 的 FDA 產品代碼為 LKV。

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。