FDA 510(k)

快速單/多藥測試杯，快速單/多藥測試浸卡

K 號：K153050 · 2016-04-26

決定日期2016-04-26

產品代碼DJG

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

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is the device name listed in this FDA 510(k) record. The listed applicant is Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-04-26 under 510(k) number K153050. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Co-Innovation Biotech Co., Ltd.. The 510(k) number is K153050.

When did Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard receive FDA 510(k) clearance?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard received FDA 510(k) clearance on 2016-04-26, under 510(k) number K153050.

Who is the listed applicant for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

The FDA 510(k) record lists Co-Innovation Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

The FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is DJG.

其他以 Co-Innovation Biotech Co., Ltd. 為申請人之記錄

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相關器械（代碼：DJG）

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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