FDA 510(k)

Pocguide 多藥檢測組合，Pocguide 多藥檢測組合OTC

K 號：K242498 · 2024-10-01

決定日期2024-10-01

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

Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC is the device name listed in this FDA 510(k) record. The listed applicant is Aicheck Biotech, Inc.. It received FDA 510(k) clearance on 2024-10-01 under 510(k) number K242498. 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 Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC?

Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Aicheck Biotech, Inc.. The 510(k) number is K242498.

When did Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC receive FDA 510(k) clearance?

Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC received FDA 510(k) clearance on 2024-10-01, under 510(k) number K242498.

Who is the listed applicant for Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC?

The FDA 510(k) record lists Aicheck Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC?

The FDA product code for Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC is NFT.

其他以 Aicheck Biotech, Inc. 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。

K242077Pocguide™ 多藥檢測杯OTC，Pocguide™ 多藥檢測杯

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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