FDA 510(k)

ImmuView S肺炎克雷伯菌及L肺炎支原體尿抗原檢測

K 號：K191184 · 2020-03-05

決定日期2020-03-05

產品代碼MJH

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is the device name listed in this FDA 510(k) record. The listed applicant is Ssi Diagnostica A/S. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K191184. The device is classified under product code MJH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Ssi Diagnostica A/S. The 510(k) number is K191184.

When did ImmuView S pneumoniae and L pneumophila Urinary Antigen Test receive FDA 510(k) clearance?

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test received FDA 510(k) clearance on 2020-03-05, under 510(k) number K191184.

Who is the listed applicant for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?

The FDA 510(k) record lists Ssi Diagnostica A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?

The FDA product code for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is MJH.

相關器械（代碼：MJH）

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K163273TRU 銀河Meridian Bioscience, Inc.

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：MJH）

官方來源