FDA 510(k)

聯繫VZV IgG HT，聯繫控制VZV IgG HT

K 號：K231214 · 2023-10-27

決定日期2023-10-27

產品代碼LFY

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

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231214. The device is classified under product code LFY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIAISON VZV IgG HT, LIAISON Control VZV IgG HT?

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is DiaSorin, Inc.. The 510(k) number is K231214.

When did LIAISON VZV IgG HT, LIAISON Control VZV IgG HT receive FDA 510(k) clearance?

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231214.

Who is the listed applicant for LIAISON VZV IgG HT, LIAISON Control VZV IgG HT?

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

What is the FDA product code for LIAISON VZV IgG HT, LIAISON Control VZV IgG HT?

The FDA product code for LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is LFY.

其他以 DiaSorin, Inc. 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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官方來源

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器材摘要

常見問題

相關臨床試驗

其他以 DiaSorin, Inc. 為申請人之記錄

官方來源