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FDA 510(k)

Flowflex COVID-19 Antigen Home Test

K-Number: K230828 · 2023-11-09

ApplicantACON Laboratories, Inc.
Decision Date2023-11-09
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Flowflex COVID-19 Antigen Home Test is a medical device manufactured by ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2023-11-09 under approval number K230828. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flowflex COVID-19 Antigen Home Test?

Flowflex COVID-19 Antigen Home Test is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by ACON Laboratories, Inc.. The 510(k) number is K230828.

When was Flowflex COVID-19 Antigen Home Test approved by the FDA?

Flowflex COVID-19 Antigen Home Test received FDA 510(k) clearance on 2023-11-09, under approval number K230828.

What company makes Flowflex COVID-19 Antigen Home Test?

Flowflex COVID-19 Antigen Home Test is manufactured by ACON Laboratories, Inc..

What is the FDA product code for Flowflex COVID-19 Antigen Home Test?

The FDA product code for Flowflex COVID-19 Antigen Home Test is QYT.

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Related Devices (Code: QYT)

K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)Guangzhou Wondfo Biotech Co., Ltd. K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc. K233842iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc. K233373Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc. K231795QuickVue COVID-19 TestQuidel Corporation K251595COVID-19 Detect Rapid Self -TestInBios International, 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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