FDA 510(k)

i-STAT PTplus 車籠，配用 i-STAT 1 系統

K 號：K220282 · 2023-07-14

決定日期2023-07-14

產品代碼GJS

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 PTplus Cartridge with the i-STAT 1 System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K220282. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the i-STAT PTplus Cartridge with the i-STAT 1 System?

i-STAT PTplus Cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Abbott Laboratories. The 510(k) number is K220282.

When did i-STAT PTplus Cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

i-STAT PTplus Cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-07-14, under 510(k) number K220282.

Who is the listed applicant for i-STAT PTplus Cartridge with the i-STAT 1 System?

FDA 510(k) 記錄中將阿培爾實驗室列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for i-STAT PTplus Cartridge with the i-STAT 1 System?

The FDA product code for i-STAT PTplus Cartridge with the i-STAT 1 System is GJS.

其他以 Abbott Laboratories 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：GJS）

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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官方來源

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