FDA 510(k)

InstaStrip Fentanyl 快速檢測（尿液）；InstaStrip Fentanyl 測試棒檢測（尿液）

K 號：K240295 · 2024-03-28

決定日期2024-03-28

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

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) is the device name listed in this FDA 510(k) record. The listed applicant is Instanosis, Inc.. It received FDA 510(k) clearance on 2024-03-28 under 510(k) number K240295. 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 InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)?

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Instanosis, Inc.. The 510(k) number is K240295.

When did InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) receive FDA 510(k) clearance?

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) received FDA 510(k) clearance on 2024-03-28, under 510(k) number K240295.

Who is the listed applicant for InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)?

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

What is the FDA product code for InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)?

The FDA product code for InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) 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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