FDA 510(k)

IMMULITE® 2000 皮質醇

K 號：K202826 · 2021-01-15

申請人Siemens Healthcare Diagnostics Products, Ltd.

決定日期2021-01-15

產品代碼CGR

諮詢委員會CH

決定相當於

器材摘要

IMMULITE® 2000 Cortisol is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K202826. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IMMULITE® 2000 Cortisol?

IMMULITE® 2000 Cortisol is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K202826.

When did IMMULITE® 2000 Cortisol receive FDA 510(k) clearance?

IMMULITE® 2000 Cortisol received FDA 510(k) clearance on 2021-01-15, under 510(k) number K202826.

Who is the listed applicant for IMMULITE® 2000 Cortisol?

FDA 510(k) 記錄將西门子醫療診斷產品有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for IMMULITE® 2000 Cortisol?

The FDA product code for IMMULITE® 2000 Cortisol is CGR.

其他以 Siemens Healthcare Diagnostics Products, Ltd. 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。

K260331IMMULITE 2000 3g過敏特異性IgE Vantage；IMMULITE 2000 系統花生過敏原（F13）K233946IMMULITE® 2000 BR-MA K213510IMMULITE/IMMULITE 1000 OM-MA，IMMULITE 2000 OM-MA K203270IMMULITE/IMMULITE® 1000 皮質醇

相關器械（代碼：CGR）

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。

K242190Access 腺皮質醇；DxC 500i臨床分析儀Beckman Coulter, Inc.K223038Access 腺皮質醇Beckman Coulter, Inc.K202136IDS皮質醇Immunodiagnostic Systems , Ltd.K203270IMMULITE/IMMULITE® 1000 皮質醇Siemens Healthcare Diagnostics Products, Ltd.

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。