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Cue COVID-19 Molecular Test

DEN220028 Class II Direct
Decision Date
2023-06-06
Sponsor / Applicant
Cue Health, Inc.

Technical Specification

510(k) Submission ID DEN220028
Product Code QWB
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.3984
Decision Date 2023-06-06
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

Cue COVID-19 Molecular Test received FDA 510(k) clearance under submission number DEN220028, sponsored by Cue Health, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2023-06-06.

Classification & Regulation

This clearance is catalogued under FDA product code QWB and 21 CFR 866.3984, within the Microbiology review panel as a Class II device.