FDA 510(k)

Flowflex Plus RSV + 流行性感冒A/B + COVID家庭檢測

K 號：K251749 · 2025-10-22

決定日期2025-10-22

產品代碼SCA

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 RSV + Flu A/B + COVID Home Test 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 2025-10-22 under 510(k) number K251749. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flowflex Plus RSV + Flu A/B + COVID Home Test?

Flowflex Plus RSV + Flu A/B + COVID Home Test is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K251749.

When did Flowflex Plus RSV + Flu A/B + COVID Home Test receive FDA 510(k) clearance?

Flowflex Plus RSV + Flu A/B + COVID Home Test received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251749.

Who is the listed applicant for Flowflex Plus RSV + Flu A/B + COVID Home Test?

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 RSV + Flu A/B + COVID Home Test?

The FDA product code for Flowflex Plus RSV + Flu A/B + COVID Home Test is SCA.

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 K251697Flowflex® Plus 醍醐A 快速測試條；Flowflex® Plus 醍醐A 快速測試卡 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

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相關器械（代碼：SCA）

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ACON Laboratories, Inc.K251092iHealth流感A&B/COVID-19快速檢測; iHealth流感A&B/COVID-19快速檢測ProIhealth Labs, Inc.K251085iHealth 流感A&B/COVID-19/RSV 快速檢測；iHealth 流感A&B/COVID-19/RSV 快速檢測 ProIhealth Labs, Inc.K251538Status™ COVID-19/流感A&BPrinceton BioMeditech Corp.K251604CareSuperb COVID-19/流感A&B抗原組合居家檢測Access Bio, Inc.K251563WELLlife 流感A&B家庭檢測；WELLlife 流感A&B檢測Wondfo USA Co, Ltd.

官方來源

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