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

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 the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) 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. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K230828.

When did Flowflex COVID-19 Antigen Home Test receive FDA 510(k) clearance?

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

Who is the listed applicant for Flowflex COVID-19 Antigen 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 COVID-19 Antigen Home Test?

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

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 SystemK250377Flowflex Plus COVID-19 + Flu A/B Home TestK232715Distinct® Digital Pregnancy Test

View all 17 devices →

Related Devices (Code: QYT)

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.

K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLCK260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLCK251916GenBody COVID-19 Ag Home TestGenbody.Inc.K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.K251753GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc.K241313OHC COVID-19 Antigen Self TestOsang, LLC

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.

↑