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FDA 510(k)

Healgen Rapid COVID-19 Antigen Test

K-Number: K232377 · 2024-04-19

ApplicantHealgen Scientific,, LLC
Decision Date2024-04-19
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Healgen Rapid COVID-19 Antigen Test is a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2024-04-19 under approval number K232377. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Healgen Rapid COVID-19 Antigen Test?

Healgen Rapid COVID-19 Antigen Test is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K232377.

When was Healgen Rapid COVID-19 Antigen Test approved by the FDA?

Healgen Rapid COVID-19 Antigen Test received FDA 510(k) clearance on 2024-04-19, under approval number K232377.

What company makes Healgen Rapid COVID-19 Antigen Test?

Healgen Rapid COVID-19 Antigen Test is manufactured by Healgen Scientific,, LLC.

What is the FDA product code for Healgen Rapid COVID-19 Antigen Test?

The FDA product code for Healgen Rapid COVID-19 Antigen Test is QVF.

Other Devices by Healgen Scientific,, LLC

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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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