FDA 510(k)

“MoFi” Cell Culture Basal Medium

K番号: K240247 · 2024-07-12

決定日2024-07-12

製品コードNDS

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

“MoFi” Cell Culture Basal Medium is the device name listed in this FDA 510(k) record. The listed applicant is Duogenic Stemcells Corporation. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K240247. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the “MoFi” Cell Culture Basal Medium?

“MoFi” Cell Culture Basal Medium is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Duogenic Stemcells Corporation. The 510(k) number is K240247.

When did “MoFi” Cell Culture Basal Medium receive FDA 510(k) clearance?

“MoFi” Cell Culture Basal Medium received FDA 510(k) clearance on 2024-07-12, under 510(k) number K240247.

Who is the listed applicant for “MoFi” Cell Culture Basal Medium?

The FDA 510(k) record lists Duogenic Stemcells Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “MoFi” Cell Culture Basal Medium?

The FDA product code for “MoFi” Cell Culture Basal Medium is NDS.

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“MoFi” Cell Culture Basal Medium

医療機器の概要

よくある質問

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