FDA 510(k)

EliA B2-Glycoprotein I IgA 免疫測定，EliA 心磷脂 IgA 免疫測定

K 號：K181329 · 2018-06-25

決定日期2018-06-25

產品代碼MSV

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

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2018-06-25 under 510(k) number K181329. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is a medical device that received FDA 510(k) clearance on 2018-06-25. The listed applicant is Phadia AB. The 510(k) number is K181329.

When did EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay receive FDA 510(k) clearance?

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay received FDA 510(k) clearance on 2018-06-25, under 510(k) number K181329.

Who is the listed applicant for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?

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

What is the FDA product code for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?

The FDA product code for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is MSV.

其他以 Phadia AB 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。

K253367EliA CTD 13 視窗 K212181ImmunoCAP過敏原f433，過敏原成分rTri a 14 LTP，麥，ImmunoCAP過敏原f416，過敏原成分rTri a 19 Omega-5麩質，麥，ImmunoCAP過敏原f449，過敏原成分rSes i 1 芝麻籽 K210902EliA Ro52, EliA Ro60 K202540EliA 骨肋板 K202541EliA RNA Pol III 医療設備規範文本 EliA RNA Pol III 医療設備規範文本 K202067EliA SmDP-S

查看所有 23 項裝置 →

相關器械（代碼：MSV）

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。

K243979Aptiva APS IgA ReagentInova Diagnostics, Inc.K162788ImmuLisa 高強化 B2GP1 IgA 抗體 ELISA，ImmuLisa 高強化 B2GP1 IgG 抗體 ELISA，ImmuLisa 高強化 B2GP1 IgM 抗體 ELISA，ImmuLisa 高強化 B2GP1 IgA/IgG/IgM 抗體 ELISAImmco Diagnostics, Inc.

官方來源

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