FDA 510(k)

ADVIA Centaur HAV IgM Assay

K 號：K161964 · 2016-10-13

決定日期2016-10-13

產品代碼LOL

諮詢委員會MI

決定Substantially Equivalent

器材摘要

ADVIA Centaur HAV IgM Assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) number K161964. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur HAV IgM Assay?

ADVIA Centaur HAV IgM Assay is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K161964.

When did ADVIA Centaur HAV IgM Assay receive FDA 510(k) clearance?

ADVIA Centaur HAV IgM Assay received FDA 510(k) clearance on 2016-10-13, under 510(k) number K161964.

Who is the listed applicant for ADVIA Centaur HAV IgM Assay?

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

What is the FDA product code for ADVIA Centaur HAV IgM Assay?

The FDA product code for ADVIA Centaur HAV IgM Assay is LOL.

其他以 Siemens Healthcare 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。

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相關器械（代碼：LOL）

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。

K260048Elecsys Anti-HAV IgMRoche Diagnostics K251995Access anti-HAV IgMBeckman Coulter, Inc.K243846Access anti-HAVBeckman Coulter, Inc.K222850HAVAb IgG IIAbbott Laboratories K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.K210272LIAISON Anti-HAVDiaSorin, Inc.

官方來源

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