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FDA 510(k)

AssureTech 安非他命測試（條狀試紙、浸卡、快速杯、一鍵分杯），AssureTech 可卡因測試（條狀試紙、浸卡、快速杯、一鍵分杯），AssureTech 吗啡測試（條狀試紙、浸卡、快速杯、一鍵分杯）

K 號：K153465 · 2016-03-31

申請人Assure Tech. (Hangzhou) Co, Ltd.
決定日期2016-03-31
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

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K153465. 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 AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)?

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K153465.

When did AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) receive FDA 510(k) clearance?

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153465.

Who is the listed applicant for AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)?

The FDA 510(k) record lists Assure Tech. (Hangzhou) Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)?

The FDA product code for AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) is DKZ.

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

其他以 Assure Tech. (Hangzhou) Co, Ltd. 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。

K233174FaStep™ 妊娠快速測試條；FaStep™ 妊娠快速測試中間條K201630AssureTech DOA 測試紙顯示面板測試，AssureTech DOA 集成杯測試K181768AssureTech 面板浸試測試，AssureTech 快速杯測試K180349AssureTech 面板浸試測試，AssureTech 快速杯測試K170049AssureTech 面板浸試測試，AssureTech 快速杯測試K161044AssureTech 甲基安非他命測試（條狀試紙、面板浸試，快速杯、一鍵分杯），AssureTech 苯二氮卓類測試（條狀試紙、面板浸試，快速杯、一鍵分杯），AssureTech 大麻測試（條狀試紙、面板浸試，快速杯、一鍵分杯）

查看所有 7 項裝置 →

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。

K240670DRI Ecstasy Plus 測試Microgenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta藥物檢測杯，Xenta藥物檢測濾卡Xenta Biomedical Science Co., Ltd.K200363Quidel Triage® 藥物檢測，94600Quidel Cardiovascular, Inc.K191099Atlas 多藥物檢測試杯，Atlas 多藥物檢測試面板Atlas MedicalK182719Quidel Triage TOX藥物檢測，94600；Quidel Triage® MeterProQuidel Cardiovascular, Inc.

官方來源

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