FDA 510(k)

鈣質2

K 號：K244042 · 2025-02-10

決定日期2025-02-10

產品代碼CJY

諮詢委員會CH

決定相當於

器材摘要

Calcium2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland. It received FDA 510(k) clearance on 2025-02-10 under 510(k) number K244042. 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 Calcium2?

Calcium2 is a medical device that received FDA 510(k) clearance on 2025-02-10. The listed applicant is Abbott Ireland. The 510(k) number is K244042.

When did Calcium2 receive FDA 510(k) clearance?

Calcium2 received FDA 510(k) clearance on 2025-02-10, under 510(k) number K244042.

Who is the listed applicant for Calcium2?

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

What is the FDA product code for Calcium2?

The FDA product code for Calcium2 is CJY.

其他以 Abbott Ireland 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。

K252357葡萄糖2

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。

K191396裕米森C1200 鈣 AS，裕米森C1200 肌酸 JaffeHORIBA ABX SAS K182042Randox 钙（Ca）Randox Laboratories, Ltd.

官方來源

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