FDA 510(k)

AssureTech 面板浸試測試，AssureTech 快速杯測試

K 號：K180349 · 2018-04-05

決定日期2018-04-05

產品代碼NFT

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 Panel Dip Tests, AssureTech Quick Cup Tests 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 2018-04-05 under 510(k) number K180349. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K180349.

When did AssureTech Panel Dip Tests, AssureTech Quick Cup Tests receive FDA 510(k) clearance?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180349.

Who is the listed applicant for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

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 Panel Dip Tests, AssureTech Quick Cup Tests?

The FDA product code for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is NFT.

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 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）K153465AssureTech 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）

查看所有 7 項裝置 →

相關器械（代碼：NFT）

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。

K261409BioTeke® 多藥尿液檢測杯Bioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech 快速測試杯；AssureTech 多藥尿液測試杯Assure Tech., LLC K261280生物篩多藥尿液檢測組合；生物篩多藥尿液家庭檢測組合Vivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip 多藥尿液檢測組合；SAFElife T-Dip 多藥尿液檢測組合 DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest 多藥尿液杯；Webest 家用多藥尿液杯WEBEST Biotech,, LLC K252550SAFElife T-Cup 多藥尿液檢測杯；SAFElife T-Cup 多藥尿液檢測杯 DxGuangzhou Wondfo Biotech Co., Ltd.

官方來源

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