FDA 510(k)

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

Número K: K251749 · 2025-10-22

Data da decisão2025-10-22

Código do produtoSCA

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam ACON Laboratories, Inc. como candidato(a)

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

Ver todos os 16 dispositivos →

Dispositivos Relacionados (Código: SCA)

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc.K251092iHealth Flu A&B/COVID-19 Rápido Test; iHealth Flu A&B/COVID-19 Rápido Test ProIhealth Labs, Inc.K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc.K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp.K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.