FDA 510(k)

DASH® SARS-CoV-2 及流感A/B檢測

K 號：K241652 · 2024-12-20

決定日期2024-12-20

產品代碼QOF

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

DASH® SARS-CoV-2 & Flu A/B Test is the device name listed in this FDA 510(k) record. The listed applicant is Nuclein, LLC. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K241652. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DASH® SARS-CoV-2 & Flu A/B Test?

DASH® SARS-CoV-2 & Flu A/B Test is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Nuclein, LLC. The 510(k) number is K241652.

When did DASH® SARS-CoV-2 & Flu A/B Test receive FDA 510(k) clearance?

DASH® SARS-CoV-2 & Flu A/B Test received FDA 510(k) clearance on 2024-12-20, under 510(k) number K241652.

Who is the listed applicant for DASH® SARS-CoV-2 & Flu A/B Test?

The FDA 510(k) record lists Nuclein, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DASH® SARS-CoV-2 & Flu A/B Test?

The FDA product code for DASH® SARS-CoV-2 & Flu A/B Test is QOF.

相關器械（代碼：QOF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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