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FDA 510(k)

全套代謝檢查、skyla 臨床化學分析儀、Minicare C300 臨床化學分析儀

K 號：K171971 · 2018-01-25

申請人Lite-On Technology Corp. H.S.P.B.
決定日期2018-01-25
產品代碼CJE
諮詢委員會CH
決定相當於

器材摘要

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Lite-On Technology Corp. H.S.P.B.. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K171971. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Lite-On Technology Corp. H.S.P.B.. The 510(k) number is K171971.

When did Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer receive FDA 510(k) clearance?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer received FDA 510(k) clearance on 2018-01-25, under 510(k) number K171971.

Who is the listed applicant for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

The FDA 510(k) record lists Lite-On Technology Corp. H.S.P.B. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

The FDA product code for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is CJE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：CJE）

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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