免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Flowflex® Plus 醍醐A 快速測試條；Flowflex® Plus 醍醐A 快速測試卡

K 號：K251697 · 2025-11-26

申請人ACON Laboratories, Inc.
決定日期2025-11-26
產品代碼GTY
諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)
決定相當於

器材摘要

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K251697. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K251697.

When did Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip receive FDA 510(k) clearance?

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip received FDA 510(k) clearance on 2025-11-26, under 510(k) number K251697.

Who is the listed applicant for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

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

What is the FDA product code for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

The FDA product code for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is GTY.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 ACON Laboratories, 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。

K261212Flowflex Plus RSV + 流行性感冒A/B + COVID 快速檢測K251749Flowflex Plus RSV + 流行性感冒A/B + COVID家庭檢測K250085On Call® 確保 GK 血糖與酮體監測系統；On Call® 確保同步 GK 血糖與酮體監測系統K250377Flowflex Plus COVID-19 + 流感A/B 家庭檢測K232715Distinct®數位懷孕檢測器K233373Flowflex® Plus COVID-19 家庭檢測

查看所有 16 項裝置 →

相關器械（代碼：GTY）

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。

K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.K212623Healgen 醫療設備快速檢測條（喉嚨拭子）Healgen Scientific,, LLCK171976索菲亞肺炎鏈球菌A+ FIA，索菲亞2分析儀Quidel Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑