FDA 510(k)

CAPI 3 免疫分類，CAPILLARYS 3 TERA，IT/IF 控制

K 號：K161928 · 2016-12-21

申請人Sebia

決定日期2016-12-21

產品代碼CFF

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

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161928. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL?

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Sebia. The 510(k) number is K161928.

When did CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL receive FDA 510(k) clearance?

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161928.

Who is the listed applicant for CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL?

The FDA 510(k) record lists Sebia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL?

The FDA product code for CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL is CFF.

其他以 Sebia 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K232027CAPI 3 新生兒 Hb，毛細血管 3 DBS 裝置 K231601FLC Kappa、FLC Lambda、FLC 控制等級 1、FLC 控制等級 2 K210623FLC Kappa、FLC Lambda、FLC 控制等級 1、FLC 控制等級 2 K203184HYDRASHIFT 2/4 艾沙珠单抗 K192095CAPI 3 免疫分類，Capillarys 3 Tera K190851HYDRASHIFT 2/4 達雷木单抗

查看所有 12 項裝置 →

相關器械（代碼：CFF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K203184HYDRASHIFT 2/4 艾沙珠单抗Sebia K192095CAPI 3 免疫分類，Capillarys 3 TeraSebia K190851HYDRASHIFT 2/4 達雷木单抗Sebia K172195HYDRASHIFT 2/4 daratumumab，daratumumab 控制用Sebia

官方來源

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