Healgen Rapid COVID-19 Antigen Test— 510(k) K232377

Name: FDA 510(k) clearance K232377
Creator: U.S. Food and Drug Administration
Published: 2024-04-19

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K232377 for Healgen Rapid COVID-19 Antigen Test, Substantially Equivalent on 2024-04-19. Applicant: Healgen Scientific,, LLC. Device class: 2.

Clearance details

Applicant: Healgen Scientific,, LLC
Product code: Code QVF
Device class: Class 2
Regulation: 21 CFR 866.3982
Advisory panel: Microbiology
Date received: 2023-08-08
Decision date: 2024-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.