FDA 510(k)

ADVIA Centaur Insulin (IRI) 主曲線材質 (MCM), ADVIA Centaur (IRI) 校正器

K 號：K162538 · 2016-11-17

決定日期2016-11-17

產品代碼JIT

諮詢委員會CH

決定相當於

器材摘要

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162538. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K162538.

When did ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator receive FDA 510(k) clearance?

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162538.

Who is the listed applicant for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

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

What is the FDA product code for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

The FDA product code for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is JIT.

其他以 Siemens Healthcare Diagnostics 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。

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相關器械（代碼：JIT）

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。

K171168維特羅斯免疫診斷產品胰島素校准器Ortho Clinical Diagnostics K170938CalSet IGF-1Roche Diagnostics K170160Abbott ARCHITECT Free T3Abbott Laboratories K163546Lumipulse G 孕酮-N 校准器Fujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N 校正器Fujirebio Diagnostics,Inc.K163544Lumipulse G 乳糖素Fujirebio Diagnostics,Inc.

官方來源

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