FDA 510(k)

ADVIA Centaur 骨髄素 (CALCT) 測試

K 號：K182012 · 2018-12-21

決定日期2018-12-21

產品代碼JKR

諮詢委員會CH

決定相當於

器材摘要

ADVIA Centaur Calcitonin (CALCT) assay is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182012. The device is classified under product code JKR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur Calcitonin (CALCT) assay?

ADVIA Centaur Calcitonin (CALCT) assay is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K182012.

When did ADVIA Centaur Calcitonin (CALCT) assay receive FDA 510(k) clearance?

ADVIA Centaur Calcitonin (CALCT) assay received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182012.

Who is the listed applicant for ADVIA Centaur Calcitonin (CALCT) assay?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Calcitonin (CALCT) assay?

The FDA product code for ADVIA Centaur Calcitonin (CALCT) assay is JKR.

其他以 Axis-Shield Diagnostics Limited 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。

K183088ADVIA Centaur 紅血球生成素 (EPO) 測試 K153551ADVCentaur Anti-CCP IgG (aCCP)試劑包括反應劑、校準劑、質控品及標準曲線材料。K160757ADVIA Centaur Active-B12 (全反式轉運型維生素B12) (AB12) 測試, ADVIA Centaur Active-B12(AB12) 質量控制，以及 ADVIA Centaur Active-B12 (AB12) 主曲線材料 (MCM)

相關器械（代碼：JKR）

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。

K252431電子系統降鈣素Roche Diagnostics GmbH

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。