FDA 510(k)

V8 Nexus 頸部血紅素超視，V8 AFSA2 血紅素控制

K 號：K192931 · 2022-04-19

決定日期2022-04-19

產品代碼GKA

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories, Corp.. It received FDA 510(k) clearance on 2022-04-19 under 510(k) number K192931. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control?

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Helena Laboratories, Corp.. The 510(k) number is K192931.

When did V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control receive FDA 510(k) clearance?

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control received FDA 510(k) clearance on 2022-04-19, under 510(k) number K192931.

Who is the listed applicant for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control?

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

What is the FDA product code for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control?

The FDA product code for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control is GKA.

其他以 Helena Laboratories, Corp. 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。

K213396SPIFE A1AT 套件

相關器械（代碼：GKA）

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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