FDA 510(k)

Status™ COVID-19/流感A&B

K 號：K251538 · 2025-11-14

決定日期2025-11-14

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

Status™ COVID-19/Flu A&B is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K251538. 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 Status™ COVID-19/Flu A&B?

Status™ COVID-19/Flu A&B is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K251538.

When did Status™ COVID-19/Flu A&B receive FDA 510(k) clearance?

Status™ COVID-19/Flu A&B received FDA 510(k) clearance on 2025-11-14, under 510(k) number K251538.

Who is the listed applicant for Status™ COVID-19/Flu A&B?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Status™ COVID-19/Flu A&B?

The FDA product code for Status™ COVID-19/Flu A&B is SCA.

其他以 Princeton BioMeditech Corp. 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。

K182157生物信流感A+B

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.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.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.K251749Flowflex Plus RSV + 流行性感冒A/B + COVID家庭檢測ACON Laboratories, Inc.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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