FDA 510(k)

ELITech臨床系統 BILIRUBIN 總量 4+1，ELITech臨床系統 BILIRUBIN 直接 4+1

K 號：K171401 · 2017-07-11

決定日期2017-07-11

產品代碼CIG

諮詢委員會CH

決定相當於

器材摘要

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K171401. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1?

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Elitechgroup. The 510(k) number is K171401.

When did ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 receive FDA 510(k) clearance?

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 received FDA 510(k) clearance on 2017-07-11, under 510(k) number K171401.

Who is the listed applicant for ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1?

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

What is the FDA product code for ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1?

The FDA product code for ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is CIG.

其他以 Elitechgroup 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。

K180559HSV 1 & 2 ELITe MGB Kit；ELITe InGenius K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I 及 ELITROL II

相關器械（代碼：CIG）

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。

K251998Atellica CH 碘化物總膽紅素 (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324總膽紅素2Abbott Ireland Diagnostics Division K190807VITROS XT 化學產品 TBIL-ALKP 製片Ortho-Clinical Diagnostics, 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。