FDA 510(k)

Quidel Triage TOX藥物檢測，94600；Quidel Triage® MeterPro

K 號：K182719 · 2019-06-19

決定日期2019-06-19

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

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Cardiovascular, Inc.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182719. 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 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro?

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Quidel Cardiovascular, Inc.. The 510(k) number is K182719.

When did Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro receive FDA 510(k) clearance?

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182719.

Who is the listed applicant for Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro?

The FDA 510(k) record lists Quidel Cardiovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro?

The FDA product code for Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is DKZ.

其他以 Quidel Cardiovascular, Inc. 為申請人之記錄

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。

K200363Quidel Triage® 藥物檢測，94600

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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