FDA 510(k)

Aptiva 胰腺疾病 IgA Reagent

K 號：K193604 · 2021-06-16

決定日期2021-06-16

產品代碼MVM

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

Aptiva Celiac Disease IgA Reagent is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K193604. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aptiva Celiac Disease IgA Reagent?

Aptiva Celiac Disease IgA Reagent is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K193604.

When did Aptiva Celiac Disease IgA Reagent receive FDA 510(k) clearance?

Aptiva Celiac Disease IgA Reagent received FDA 510(k) clearance on 2021-06-16, under 510(k) number K193604.

Who is the listed applicant for Aptiva Celiac Disease IgA Reagent?

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

What is the FDA product code for Aptiva Celiac Disease IgA Reagent?

The FDA product code for Aptiva Celiac Disease IgA Reagent is MVM.

其他以 Inova Diagnostics, Inc. 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。

K243979Aptiva APS IgA Reagent K223093Aptiva APS IgG Reagent; Aptiva APS IgM Reagent K213403Aptiva CTD Essential Reagent K200230Aptiva 胰腺疾病 IgG Reagent K192916NOVA Lite DAPI dsDNA Crithidia luciliae 套件 K190088QUANTA Flash RF IgM試劑，QUANTA Flash RF IgA試劑

查看所有 16 項裝置 →

相關器械（代碼：MVM）

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。

K200230Aptiva 胰腺疾病 IgG ReagentInova Diagnostics, Inc.K181871EliA Celikey IgG 免疫測定法；EliA GliadinDP IgA 免疫測定法；EliA GliadinDP IgG 免疫測定法Phadia AB K183313EUROIMMUN 防組織轉谷氨鰐酶 ELISA (IgA)，EUROIMMUN 防組織轉谷氨鰐酶 ELISA (IgG)Euroimmun Us, Inc.

官方來源

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