FDA 510(k)

BD Veritor システムフル A + B 流感の迅速検出用 CLIA 免許証不要キット

K番号: K160161 · 2016-02-24

決定日2016-02-24

製品コードPSZ

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

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K160161. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K160161.

When did BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit receive FDA 510(k) clearance?

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit received FDA 510(k) clearance on 2016-02-24, under 510(k) number K160161.

Who is the listed applicant for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

The FDA product code for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is PSZ.

申請者としてBecton, Dickinson & COを記載するその他の記録

K160164BD Veritor システムフル速報型インフルエンザA+B検出用ラボキット

公式ソース

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