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FDA 510(k)

Flowflex Plus COVID-19 + Flu A/B Home Test

K-Number: K250377 · 2025-05-10

ApplicantACON Laboratories, Inc.
Decision Date2025-05-10
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Flowflex Plus COVID-19 + Flu A/B Home Test is a medical device manufactured by ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-05-10 under approval number K250377. 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 COVID-19 + Flu A/B Home Test?

Flowflex Plus COVID-19 + Flu A/B Home Test is a medical device that received FDA 510(k) clearance on 2025-05-10. It is manufactured by ACON Laboratories, Inc.. The 510(k) number is K250377.

When was Flowflex Plus COVID-19 + Flu A/B Home Test approved by the FDA?

Flowflex Plus COVID-19 + Flu A/B Home Test received FDA 510(k) clearance on 2025-05-10, under approval number K250377.

What company makes Flowflex Plus COVID-19 + Flu A/B Home Test?

Flowflex Plus COVID-19 + Flu A/B Home Test is manufactured by ACON Laboratories, Inc..

What is the FDA product code for Flowflex Plus COVID-19 + Flu A/B Home Test?

The FDA product code for Flowflex Plus COVID-19 + Flu A/B Home Test is SCA.

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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. K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.

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.

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