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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K241652
Device Name DASH® SARS-CoV-2 & Flu A/B Test
Applicant
Nuclein, LLC
8305 Cross Park Dr.
Austin,  TX  78754
Applicant Contact Ben Treece
Correspondent
Nuclein, LLC
8305 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact Chelynne Lee
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Code
NSU  
Date Received06/07/2024
Decision Date 12/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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