FDA 510(k)

3M Attest ラピッドリードアウト生物学的指標

K番号: K160546 · 2016-06-09

決定日2016-06-09

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

3M Attest Rapid Readout Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K160546. 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 3M Attest Rapid Readout Biological Indicator?

3M Attest Rapid Readout Biological Indicator is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is 3M Company. The 510(k) number is K160546.

When did 3M Attest Rapid Readout Biological Indicator receive FDA 510(k) clearance?

3M Attest Rapid Readout Biological Indicator received FDA 510(k) clearance on 2016-06-09, under 510(k) number K160546.

Who is the listed applicant for 3M Attest Rapid Readout Biological Indicator?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Attest Rapid Readout Biological Indicator?

The FDA product code for 3M Attest Rapid Readout Biological Indicator is FRC.

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