FDA 510(k)

ADVIA Centaur CA 15-3 assay

K 號：K192777 · 2019-11-22

決定日期2019-11-22

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

ADVIA Centaur CA 15-3 assay 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 2019-11-22 under 510(k) number K192777. 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 ADVIA Centaur CA 15-3 assay?

ADVIA Centaur CA 15-3 assay is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K192777.

When did ADVIA Centaur CA 15-3 assay receive FDA 510(k) clearance?

ADVIA Centaur CA 15-3 assay received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192777.

Who is the listed applicant for ADVIA Centaur CA 15-3 assay?

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。

What is the FDA product code for ADVIA Centaur CA 15-3 assay?

The FDA product code for ADVIA Centaur CA 15-3 assay is MOI.