FDA 510(k)

SAFECARE多藥尿液檢測杯，SAFECARE多藥尿液檢測濾紙卡

K 號：K201120 · 2020-05-27

申請人Safecare Biotech (Hangzhou) Co., Ltd.

決定日期2020-05-27

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

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is the device name listed in this FDA 510(k) record. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K201120. 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 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K201120.

When did SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card receive FDA 510(k) clearance?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card received FDA 510(k) clearance on 2020-05-27, under 510(k) number K201120.

Who is the listed applicant for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

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

What is the FDA product code for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

The FDA product code for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is NFT.

其他以 Safecare Biotech (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。

K242767Safecare 尿路感染檢測器 K240654SAFECARE 藥物濾尿試條；SAFECARE FYL 濾尿試條 K202453SAFECARE多藥尿液檢測杯，SAFECARE多藥尿液檢測濾卡 K200133hCG 尿試紙，hCG 尿試條，hCG 尿試中間試紙 K191924SAFECARE® THC 肾上腺素尿液試條檢測 K182654SAFECARE多藥尿液檢測杯，SAFECARE多藥尿液檢測濾紙卡

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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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