FDA 510(k)

i-STAT CHEM8+ 車籠，配用 i-STAT 1 系統

K 號：K183680 · 2020-02-28

決定日期2020-02-28

產品代碼JPI

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

i-STAT CHEM8+ cartridge with the i-STAT 1 System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K183680. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the i-STAT CHEM8+ cartridge with the i-STAT 1 System?

i-STAT CHEM8+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K183680.

When did i-STAT CHEM8+ cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

i-STAT CHEM8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2020-02-28, under 510(k) number K183680.

Who is the listed applicant for i-STAT CHEM8+ cartridge with the i-STAT 1 System?

The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-STAT CHEM8+ cartridge with the i-STAT 1 System?

The FDA product code for i-STAT CHEM8+ cartridge with the i-STAT 1 System is JPI.

其他以 Abbott Point of Care, Inc. 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。

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相關器械（代碼：JPI）

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。

K163342i-STAT 血球比容測試搭配 i-STAT Alinity 系統Abbott Laboratories

官方來源

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