FDA 510(k)

Atlas 多藥物檢測試杯，Atlas 多藥物檢測試面板

K 號：K191099 · 2019-10-03

決定日期2019-10-03

產品代碼DKZ

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

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Medical. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K191099. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Atlas Medical. The 510(k) number is K191099.

When did Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel receive FDA 510(k) clearance?

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel received FDA 510(k) clearance on 2019-10-03, under 510(k) number K191099.

Who is the listed applicant for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?

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

What is the FDA product code for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel?

The FDA product code for Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel is DKZ.

相關器械（代碼：DKZ）

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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官方來源

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