FDA 510(k)

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

K 號：K244043 · 2025-02-27

決定日期2025-02-27

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

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-02-27 under 510(k) number K244043. 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 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup?

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K244043.

When did AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup receive FDA 510(k) clearance?

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup received FDA 510(k) clearance on 2025-02-27, under 510(k) number K244043.

Who is the listed applicant for AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup?

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

What is the FDA product code for AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup?

The FDA product code for AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup is NFT.

其他以 Hangzhou AllTest Biotech 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。

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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。

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官方來源

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