FDA 510(k)

Amylase2

K 號：K210633 · 2022-05-26

決定日期2022-05-26

產品代碼JFJ

諮詢委員會CH

決定相當於

器材摘要

Amylase2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K210633. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Amylase2?

Amylase2 is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K210633.

When did Amylase2 receive FDA 510(k) clearance?

Amylase2 received FDA 510(k) clearance on 2022-05-26, under 510(k) number K210633.

Who is the listed applicant for Amylase2?

The FDA 510(k) record lists Abbott Ireland Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amylase2?

The FDA product code for Amylase2 is JFJ.

其他以 Abbott Ireland Diagnostics Division 為申請人之記錄

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相關器械（代碼：JFJ）

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。

K191454Atellica CH 麦芽糖_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE 直接，alpha-AMYLASE EPS，alpha-AMYLASE 胰臟，直接膽紅素，總膽紅素Biosystems S.A.

官方來源

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