Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K251749 · 2025-10-22

ApplicantACON Laboratories, Inc.
Decision Date2025-10-22
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Flowflex Plus RSV + Flu A/B + COVID Home Test is a medical device manufactured by ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-10-22 under approval number K251749. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by ACON Laboratories, Inc.. The 510(k) number is K251749.

When was Flowflex Plus RSV + Flu A/B + COVID Home Test approved by the FDA?

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

What company makes Flowflex Plus RSV + Flu A/B + COVID Home Test?

Flowflex Plus RSV + Flu A/B + COVID Home Test is manufactured by ACON Laboratories, Inc..

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.

Other Devices by ACON Laboratories, Inc.

K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System K180504Mission Lipid Panel Monitoring System K180196On Call Express Mobile Blood Glucose Monitoring System K192175On Call Express II Blood Glucose Monitoring System

View all 15 devices →

Related Devices (Code: SCA)

DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑