FDA 510(k)

B.アナサクシスリアルタイムPCRアッセイ

K番号: K192871 · 2019-11-07

申請者Centers for Disease Control and Prevention

決定日2019-11-07

製品コードNHT

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

B. anthracis Real-time PCR Assay is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192871. The device is classified under product code NHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the B. anthracis Real-time PCR Assay?

B. anthracis Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K192871.

When did B. anthracis Real-time PCR Assay receive FDA 510(k) clearance?

B. anthracis Real-time PCR Assay received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192871.

Who is the listed applicant for B. anthracis Real-time PCR Assay?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B. anthracis Real-time PCR Assay?

The FDA product code for B. anthracis Real-time PCR Assay is NHT.

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