FDA 510(k)

裕米森C1200 鈣 AS，裕米森C1200 肌酸 Jaffe

K 號：K191396 · 2019-07-26

決定日期2019-07-26

產品代碼CJY

諮詢委員會CH

決定相當於

器材摘要

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191396. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is HORIBA ABX SAS. The 510(k) number is K191396.

When did Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe receive FDA 510(k) clearance?

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191396.

Who is the listed applicant for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?

FDA 510(k) 記錄將 HORIBA ABX SAS 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?

The FDA product code for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is CJY.

其他以 HORIBA ABX SAS 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。

K260781裕米森 H550 K232946裕米森H2500 K193649裕米森C1200肌肝酐PAP K193525裕米森C1200免疫球蛋白A，裕米森C1200免疫球蛋白G，裕米森C1200免疫球蛋白M K192028裕米森C1200 CRP K191562裕米森C1200鐵蛋白，裕米森C1200轉鐵蛋白，裕米森C1200類風濕因子

查看所有 10 項裝置 →

相關器械（代碼：CJY）

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。

K244042鈣質2Abbott Ireland K182042Randox 钙（Ca）Randox Laboratories, Ltd.

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。