FDA 510(k)

CAPI 3 新生兒 Hb，毛細血管 3 DBS 裝置

K 號：K232027 · 2024-04-04

申請人Sebia

決定日期2024-04-04

產品代碼GKA

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K232027. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument?

CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Sebia. The 510(k) number is K232027.

When did CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument receive FDA 510(k) clearance?

CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument received FDA 510(k) clearance on 2024-04-04, under 510(k) number K232027.

Who is the listed applicant for CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument?

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 NEONAT Hb, CAPILLARYS 3 DBS Instrument?

The FDA product code for CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument is GKA.

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。

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 K180762CAPI 3 血紅素(E)

查看所有 12 項裝置 →

相關器械（代碼：GKA）

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。

K222635預設解決方案系統Trinity Biotech (Primus Corporation, Dba Trinity Biotech)K192931V8 Nexus 頸部血紅素超視，V8 AFSA2 血紅素控制Helena Laboratories, Corp.K180762CAPI 3 血紅素(E)Sebia K171664新生兒血色素變異體系統，配備GDM及HbReview軟體Bio-Rad Laboratories, Inc.

官方來源

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