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FDA 510(k)

SAFECARE多藥尿液檢測杯，SAFECARE多藥尿液檢測濾紙卡

K 號：K182654 · 2018-11-19

申請人Safecare Biotech (Hangzhou) Co., Ltd.
決定日期2018-11-19
產品代碼NGG
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 2018-11-19 under 510(k) number K182654. The device is classified under product code NGG. 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 2018-11-19. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K182654.

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 2018-11-19, under 510(k) number K182654.

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 NGG.

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 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K201120SAFECARE多藥尿液檢測杯，SAFECARE多藥尿液檢測濾紙卡K191924SAFECARE® THC 肾上腺素尿液試條檢測

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