FDA 510(k)

SEKURE 磷酸激酶測試

K 號：K182702 · 2019-04-17

決定日期2019-04-17

產品代碼CGS

諮詢委員會CH

決定相當於

器材摘要

SEKURE Creatine Kinase Assay is the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K182702. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SEKURE Creatine Kinase Assay?

SEKURE Creatine Kinase Assay is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K182702.

When did SEKURE Creatine Kinase Assay receive FDA 510(k) clearance?

SEKURE Creatine Kinase Assay received FDA 510(k) clearance on 2019-04-17, under 510(k) number K182702.

Who is the listed applicant for SEKURE Creatine Kinase Assay?

The FDA 510(k) record lists Sekisui Diagnostics P.E.I., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEKURE Creatine Kinase Assay?

The FDA product code for SEKURE Creatine Kinase Assay is CGS.

其他以 Sekisui Diagnostics P.E.I., Inc. 為申請人之記錄

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相關器械（代碼：CGS）

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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