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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 K241806
Device Name Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
Applicant
Life Technologies Corporation
6055 Sunol Boulevard
Pleasanton,  CA  94566
Applicant Contact Stacey Moltchanoff
Correspondent
Life Technologies Corporation
6055 Sunol Boulevard
Pleasanton,  CA  94566
Correspondent Contact Stacey Moltchanoff
Regulation Number866.3981
Classification Product Code
QOF  
Date Received06/21/2024
Decision Date 01/08/2025
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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