FDA 510(k)

Flowflex Plus RSV + Flu A/B + COVID Home Test

K-번호: K251749 · 2025-10-22

결정일2025-10-22

제품 코드SCA

자문 위원회MI

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

ACON Laboratories, Inc.를 신청인으로 등재한 기타 기록

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid Test K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System K250377Flowflex Plus COVID-19 + Flu A/B Home Test K232715Distinct® Digital Pregnancy Test K233373Flowflex® Plus COVID-19 Home Test

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