FDA 510(k)

VITROS XT 化學產品 TRIG-CHOL 製品

K 號：K190490 · 2019-03-27

決定日期2019-03-27

產品代碼CHH

諮詢委員會CH

決定相當於

器材摘要

VITROS XT Chemistry Products TRIG-CHOL Slides 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 2019-03-27 under 510(k) number K190490. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITROS XT Chemistry Products TRIG-CHOL Slides?

VITROS XT Chemistry Products TRIG-CHOL Slides is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190490.

When did VITROS XT Chemistry Products TRIG-CHOL Slides receive FDA 510(k) clearance?

VITROS XT Chemistry Products TRIG-CHOL Slides received FDA 510(k) clearance on 2019-03-27, under 510(k) number K190490.

Who is the listed applicant for VITROS XT Chemistry Products TRIG-CHOL Slides?

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 XT Chemistry Products TRIG-CHOL Slides?

The FDA product code for VITROS XT Chemistry Products TRIG-CHOL Slides is CHH.

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。

K252393VITROS 免疫診斷產品 hs Troponin I 製劑包 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 K190326VITROS XT化學產品 UREA-CREA薄片

查看所有 11 項裝置 →

相關器械（代碼：CHH）

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。

K251091脂質Truvian Health K232404膽固醇；高密度膽固醇；低密度膽固醇；三酸甘油脂Medicon Hellas S.A K203597膽固醇2Abbott Ireland Diagnostics Division K181373延長脂質面板測試Laboratory Corporation of America Holdings K180504使命脂質面板監測系統ACON Laboratories, Inc.K163406使命膽固醇監測系統，使命膽固醇專業監測系統ACON Laboratories, Inc.

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。