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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name over-the-counter molecular test to detect sars-cov-2 from clinical specimens
510(k) Number K232643
Device Name Cue COVID-19 Molecular Test
Applicant
Cue Health Inc.
4980 Carroll Canyon Road, Suite 100
San Diego,  CA  92121
Applicant Contact Sharon Young
Correspondent
Cue Health Inc.
4980 Carroll Canyon Road, Suite 100
San Diego,  CA  92121
Correspondent Contact Sharon Young
Regulation Number866.3984
Classification Product Code
QWB  
Date Received08/30/2023
Decision Date 11/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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