FDA 510(k)

RCRP Flex 製劑芯

K 號：K221119 · 2023-03-17

決定日期2023-03-17

產品代碼DCN

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

RCRP Flex reagent cartridge 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 2023-03-17 under 510(k) number K221119. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RCRP Flex reagent cartridge?

RCRP Flex reagent cartridge is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K221119.

When did RCRP Flex reagent cartridge receive FDA 510(k) clearance?

RCRP Flex reagent cartridge received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221119.

Who is the listed applicant for RCRP Flex reagent cartridge?

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 RCRP Flex reagent cartridge?

The FDA product code for RCRP Flex reagent cartridge is DCN.