FDA 510(k)

維拉美德 Borrela 全功能 ViraChip 檢測套件

K 號：K220016 · 2022-08-19

決定日期2022-08-19

產品代碼LSR

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

Viramed Borrela All-In-One ViraChip Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Viramed Biotech AG. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220016. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Viramed Borrela All-In-One ViraChip Test Kit?

Viramed Borrela All-In-One ViraChip Test Kit is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Viramed Biotech AG. The 510(k) number is K220016.

When did Viramed Borrela All-In-One ViraChip Test Kit receive FDA 510(k) clearance?

Viramed Borrela All-In-One ViraChip Test Kit received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220016.

Who is the listed applicant for Viramed Borrela All-In-One ViraChip Test Kit?

The FDA 510(k) record lists Viramed Biotech AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viramed Borrela All-In-One ViraChip Test Kit?

The FDA product code for Viramed Borrela All-In-One ViraChip Test Kit is LSR.

其他以 Viramed Biotech AG 為申請人之記錄

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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相關器械（代碼：LSR）

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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