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FDA 510(k)

DPP Zika IgM系統、DPP Zika IgM系統控制包、以及DPP微讀取器

K 號：K200506 · 2020-06-03

申請人Chembio Diagnostic Systems
決定日期2020-06-03
產品代碼QFO
諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)
決定相當於

器材摘要

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is the device name listed in this FDA 510(k) record. The listed applicant is Chembio Diagnostic Systems. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K200506. The device is classified under product code QFO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Chembio Diagnostic Systems. The 510(k) number is K200506.

When did DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader receive FDA 510(k) clearance?

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200506.

Who is the listed applicant for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

The FDA 510(k) record lists Chembio Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader?

The FDA product code for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is QFO.

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。

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相關器械（代碼：QFO）

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。

K192046LIAISON XL Zika Capture IgM II 及 LIAISON XL Zika Capture IgM II 控制組DiaSorin, Inc.K191578ADVIA Centaur Zika檢測, ADVIA Centaur Zika抗體 (100次測試), ADVIA Centaur Zika IgM (50次測試), ADVIA Centaur Zika抗體質控, ADVIA Centaur Zika IgM質控Siemens Healthcare Diagnostics, Inc.

官方來源

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