FDA 510(k)

テラジェーン・ビオノヴァ、テラジェーン・ビオノヴァ、テラジェーン・インテグロン、テラジェーン・シンタペ、テラジェーン・ケムディー

K番号: K191021 · 2019-09-13

決定日2019-09-13

製品コードFRC

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye is the device name listed in this FDA 510(k) record. The listed applicant is Terragene S.A.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K191021. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye?

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Terragene S.A.. The 510(k) number is K191021.

When did Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye receive FDA 510(k) clearance?

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye received FDA 510(k) clearance on 2019-09-13, under 510(k) number K191021.

Who is the listed applicant for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye?

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

What is the FDA product code for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye?

The FDA product code for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye is FRC.

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