FDA 510(k)

Elecsys CA 15-3 II

K 號：K171605 · 2018-02-20

決定日期2018-02-20

產品代碼MOI

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

Elecsys CA 15-3 II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2018-02-20 under 510(k) number K171605. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elecsys CA 15-3 II?

Elecsys CA 15-3 II is a medical device that received FDA 510(k) clearance on 2018-02-20. The listed applicant is Roche Diagnostics. The 510(k) number is K171605.

When did Elecsys CA 15-3 II receive FDA 510(k) clearance?

Elecsys CA 15-3 II received FDA 510(k) clearance on 2018-02-20, under 510(k) number K171605.

Who is the listed applicant for Elecsys CA 15-3 II?

FDA 510(k) 記錄將羅氏醫學診斷列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Elecsys CA 15-3 II?

The FDA product code for Elecsys CA 15-3 II is MOI.