FDA 510(k)

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

K 號：K161139 · 2016-07-22

決定日期2016-07-22

產品代碼LYR

諮詢委員會MI

決定Substantially Equivalent

器材摘要

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K161139. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set?

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is DiaSorin, Inc.. The 510(k) number is K161139.

When did LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set receive FDA 510(k) clearance?

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161139.

Who is the listed applicant for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set?

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

What is the FDA product code for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set?

The FDA product code for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is LYR.

其他以 DiaSorin, 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：LYR）

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。

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.

官方來源

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