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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 the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-05-10 under 510(k) 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. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K250377.

When did Flowflex Plus COVID-19 + Flu A/B Home Test receive FDA 510(k) clearance?

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

Who is the listed applicant for Flowflex Plus COVID-19 + Flu A/B 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 COVID-19 + Flu A/B Home Test?

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

Other records listing ACON Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestK251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripK251749Flowflex Plus RSV + Flu A/B + COVID Home TestK250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemK232715Distinct® Digital Pregnancy TestK233373Flowflex® Plus COVID-19 Home Test

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Related Devices (Code: SCA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc.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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