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FDA 510(k)

卡羅來納液體化學公司可卡因及可卡因代謝物酶免疫測定（COCM）試驗系統

K 號：K213211 · 2022-01-27

申請人Carolina Liquid Chemistries Corp.
決定日期2022-01-27
產品代碼DIO
諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯： 本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。
決定相當於

器材摘要

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K213211. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System?

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Carolina Liquid Chemistries Corp.. The 510(k) number is K213211.

When did Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System receive FDA 510(k) clearance?

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System received FDA 510(k) clearance on 2022-01-27, under 510(k) number K213211.

Who is the listed applicant for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System?

The FDA 510(k) record lists Carolina Liquid Chemistries Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System?

The FDA product code for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is DIO.

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：DIO）

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。

K211973DRI 可卡因代謝物測試Microgenics CorporationK191638點尖科學可卡因代謝物酵素免疫分析Medtest DXK181499DRI 可卡因代謝物測試Microgenics CorporationK170293Emit II Plus 可卡因代謝物測試Siemens Healthcare Diagnostics, Inc.K163570卡羅來納液體化學公司可卡因及可卡因代謝物測試系統（COCM）Carolina Liquid Chemistries CorporationK162395MP DOA-10面板測試杯，MP DOA-11面板測試杯Mp Biomedicals, LLC

官方來源

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