FDA 510(k)

ETERBIO 藥物濃度快速檢測儀（膠體金）；ETERBIO 藥物濃度家庭檢測套件

K 號：K243064 · 2024-11-20

決定日期2024-11-20

產品代碼NGL

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

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is the device name listed in this FDA 510(k) record. The listed applicant is Eterbio, Inc.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K243064. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Eterbio, Inc.. The 510(k) number is K243064.

When did ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test receive FDA 510(k) clearance?

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test received FDA 510(k) clearance on 2024-11-20, under 510(k) number K243064.

Who is the listed applicant for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

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

What is the FDA product code for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

The FDA product code for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is NGL.

相關器械（代碼：NGL）

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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