FDA 510(k)

Alinity i 全量 β-hCG 試劑套件，GLP系統追蹤

K 號：K230937 · 2023-06-05

決定日期2023-06-05

產品代碼DHA

諮詢委員會CH

決定相當於

器材摘要

Alinity i Total ß-hCG Reagent Kit, GLP systems Track is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K230937. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

Alinity i Total ß-hCG Reagent Kit, GLP systems Track is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Abbott Laboratories. The 510(k) number is K230937.

When did Alinity i Total ß-hCG Reagent Kit, GLP systems Track receive FDA 510(k) clearance?

Alinity i Total ß-hCG Reagent Kit, GLP systems Track received FDA 510(k) clearance on 2023-06-05, under 510(k) number K230937.

Who is the listed applicant for Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

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 Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

The FDA product code for Alinity i Total ß-hCG Reagent Kit, GLP systems Track is DHA.

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。

K262156Anti-HCV Next K252424Anti-HCV Next K243500ARCHITECT庆大霉素 K243168Alinity i 飛蚊症IgG K243283Alinity h-series 系統 K233932Alinity i Toxo IgM

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相關器械（代碼：DHA）

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。

K233581VITROS 免疫診斷產品全 β-hCG II 製劑包Ortho Clinical Diagnostics K223690iFlash-HCG；化學發光免疫分析儀（型號：iFlash 3000-C）Shenzhen Yhlo Biotech Co., Ltd.K230790Alinity i 全量 β-hCG 試劑套件，Alinity c 葡萄糖試劑套件，Alinity c ICT 樣本稀釋劑，Alinity ci-seriesAbbott Laboratories K221990Access 全總βhCG (第5個IS)Beckman Coulter, Inc.K212221迪亞茲美DZ-Lite iFlash全總beta-hCG測試，迪亞茲美DZ-Lite iFlash 1800化學發光免疫分析儀Diazyme Laboratories, Inc.K203227Elecsys HCG STATRoche Diagnostics

官方來源

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