FDA 510(k)

i-STAT TBI 製劑與i-STAT Alinity 系統

K 號：K234143 · 2024-03-27

決定日期2024-03-27

產品代碼QAT

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

i-STAT TBI Cartridge with the i-STAT Alinity System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K234143. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the i-STAT TBI Cartridge with the i-STAT Alinity System?

i-STAT TBI Cartridge with the i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Abbott Point of Care. The 510(k) number is K234143.

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

i-STAT TBI Cartridge with the i-STAT Alinity System received FDA 510(k) clearance on 2024-03-27, under 510(k) number K234143.

Who is the listed applicant for i-STAT TBI Cartridge with the i-STAT Alinity System?

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

What is the FDA product code for i-STAT TBI Cartridge with the i-STAT Alinity System?

The FDA product code for i-STAT TBI Cartridge with the i-STAT Alinity System is QAT.

相關器械（代碼：QAT）

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。

K240279VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc.K232669TBIAbbott Laboratories K223602外傷性腦部損傷（TBI）測試Abbott Laboratories K201778i-STAT TBI 血漿卡匣，配用 i-STAT Alinity 系統Abbott Laboratories

官方來源

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