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Healgen Rapid Check COVID-19/Flu A&B Antigen Test

DEN240029 Class II Direct
Decision Date
2024-10-07
Sponsor / Applicant
Healgen

Technical Specification

510(k) Submission ID DEN240029
Product Code SCA
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.3987
Decision Date 2024-10-07
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Healgen Rapid Check COVID-19/Flu A&B Antigen Test received FDA 510(k) clearance under submission number DEN240029, sponsored by Healgen. The device was reviewed via the Direct premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2024-10-07.

Classification & Regulation

This clearance is catalogued under FDA product code SCA and 21 CFR 866.3987, within the Microbiology review panel as a Class II device.