FDA 510(k)

ImmuView S肺炎球菌およびL肺炎球菌尿抗原検査

K番号: K191184 · 2020-03-05

決定日2020-03-05

製品コードMJH

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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ImmuView S肺炎球菌およびL肺炎球菌尿抗原検査

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：MJH）

公式ソース