FDA 510(k)

快速尿液芬太尼（FYL）試紙；快速尿液芬太尼（FYL）試滴卡

K 號：K241100 · 2024-05-22

決定日期2024-05-22

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

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard is the device name listed in this FDA 510(k) record. The listed applicant is Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K241100. 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 Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard?

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Co-Innovation Biotech Co., Ltd.. The 510(k) number is K241100.

When did Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard receive FDA 510(k) clearance?

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard received FDA 510(k) clearance on 2024-05-22, under 510(k) number K241100.

Who is the listed applicant for Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard?

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

What is the FDA product code for Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard?

The FDA product code for Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard is NGL.

其他以 Co-Innovation 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。

K231904快速芬太尼（FYL）試紙，快速芬太尼（FYL）試滴卡 K232732快速大麻（THC）試紙 20，快速大麻（THC）試滴卡 20，快速大麻（THC）試紙 50，快速大麻（THC）試滴卡 50 K213808共同創新一步人類胎盤激素（HCG）測試條，共同創新一步人類胎盤激素（HCG）測試卡式，共同創新一步人類胎盤激素（HCG）測試中間流 K153050快速單/多藥測試杯，快速單/多藥測試浸卡

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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