FDA 510(k)

HbA1c先進版

K 號：K182651 · 2019-01-16

決定日期2019-01-16

產品代碼PDJ

諮詢委員會CH

決定相當於

器材摘要

HbA1c Advanced is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K182651. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HbA1c Advanced?

HbA1c Advanced is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Beckman Coulter Ireland, Inc.. The 510(k) number is K182651.

When did HbA1c Advanced receive FDA 510(k) clearance?

HbA1c Advanced received FDA 510(k) clearance on 2019-01-16, under 510(k) number K182651.

Who is the listed applicant for HbA1c Advanced?

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

What is the FDA product code for HbA1c Advanced?

The FDA product code for HbA1c Advanced is PDJ.

其他以 Beckman Coulter Ireland, Inc. 為申請人之記錄

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相關器械（代碼：PDJ）

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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