FDA 510(k)

VITROS化學產品 Cl- 滑片

K 號：K162020 · 2016-12-16

決定日期2016-12-16

產品代碼CGZ

諮詢委員會CH

決定相當於

器材摘要

VITROS Chemistry Products Cl- 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 2016-12-16 under 510(k) number K162020. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITROS Chemistry Products Cl- Slides?

VITROS Chemistry Products Cl- Slides is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K162020.

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

VITROS Chemistry Products Cl- Slides received FDA 510(k) clearance on 2016-12-16, under 510(k) number K162020.

Who is the listed applicant for VITROS Chemistry Products Cl- 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 Cl- Slides?

The FDA product code for VITROS Chemistry Products Cl- Slides is CGZ.

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：CGZ）

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。

K182072VITROS化學產品Cl-Slides，VITROS化學產品ECO2 Slides，VITROS化學產品GLU SlidesOrtho-Clinical Diagnostics, Inc.K170320Alinity c ICT樣本稀釋劑Abbott Laboratories

官方來源

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