FDA 510(k)

宙斯 IFA ANA HEp-2 檢測系統，宙斯 dIFine

K 號：K201956 · 2022-04-29

決定日期2022-04-29

產品代碼DHN

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

Zeus IFA ANA HEp-2 Test System, Zeus dIFine is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K201956. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

Zeus IFA ANA HEp-2 Test System, Zeus dIFine is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K201956.

When did Zeus IFA ANA HEp-2 Test System, Zeus dIFine receive FDA 510(k) clearance?

Zeus IFA ANA HEp-2 Test System, Zeus dIFine received FDA 510(k) clearance on 2022-04-29, under 510(k) number K201956.

Who is the listed applicant for Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

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

What is the FDA product code for Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

The FDA product code for Zeus IFA ANA HEp-2 Test System, Zeus dIFine is DHN.

其他以 Zeus Scientific, 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。

K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS ELISA Borrelia burgdorferi IgG 測試系統 K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS ELISA Borrelia burgdorferi IgM 測試系統 K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS ELISA Borrelia burgdorferi IgG/IgM 測試系統

相關器械（代碼：DHN）

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。

K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma，HELIOS 全自動 IFA 系統Aesku Systems GmbH&Co.Kg K160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。