FDA 510(k)

VITROS化學產品GLU滑片

K 號：K163433 · 2017-09-18

決定日期2017-09-18

產品代碼CGA

諮詢委員會CH

決定相當於

器材摘要

VITROS Chemistry Products GLU Slides is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K163433. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITROS Chemistry Products GLU Slides?

VITROS Chemistry Products GLU Slides is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K163433.

When did VITROS Chemistry Products GLU Slides receive FDA 510(k) clearance?

VITROS Chemistry Products GLU Slides received FDA 510(k) clearance on 2017-09-18, under 510(k) number K163433.

Who is the listed applicant for VITROS Chemistry Products GLU Slides?

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

What is the FDA product code for VITROS Chemistry Products GLU Slides?

The FDA product code for VITROS Chemistry Products GLU Slides is CGA.

其他以 Ortho Clinical 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。

K241534VITROS 免疫診斷產品梅毒試劑組 K233581VITROS 免疫診斷產品全 β-hCG II 製劑包 K221197VITROS 免疫診斷產品完整 PTH II 製劑包 K231517維特羅斯免疫診斷產品CEA試劑包 K231525VITROS 免疫診斷產品 CA 19-9TM 试剂包 K221355VITROS 免疫診斷產品 CA 125 II 製劑包

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相關器械（代碼：CGA）

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。

K252488ABL90 FLEX PLUS 系統Radiometer Medicals Aps K210933YSI 2900C 生化分析仪Ysi, Inc.K220328EasyStat 300Medica Corporation K223179Cholestech LDX™ 系統Alere San Diego, Inc.K223755i-STAT G 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.K223710i-STAT CG8+ 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.

官方來源

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