FDA 510(k)

VITROS 免疫診斷產品 hs Troponin I 製劑包

K 號：K252393 · 2025-10-29

決定日期2025-10-29

產品代碼MMI

諮詢委員會CH

決定相當於

器材摘要

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K252393. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K252393.

When did VITROS Immunodiagnostic Products hs Troponin I Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack received FDA 510(k) clearance on 2025-10-29, under 510(k) number K252393.

Who is the listed applicant for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is MMI.

其他以 Ortho-Clinical Diagnostics, Inc. 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。

K210858VITROS化學產品PHBR滑片 K191316VITROS XT 化學產品 ALB-TP 製品 K190807VITROS XT 化學產品 TBIL-ALKP 製片 K190520VITROS XT化學產品 GLU-Ca 製片 K190490VITROS XT 化學產品 TRIG-CHOL 製品 K190326VITROS XT化學產品 UREA-CREA薄片

查看所有 11 項裝置 →

相關器械（代碼：MMI）

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。

K253051i-STAT hs-TnI 車籠，配用 i-STAT Alinity 系統Abbott Point of Care, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.K241165Atellica® IM 高敏度 Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.K231974PATHFAST®hs-cTnI-IIPhc Corporation

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。