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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 K230956
Device Name BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System
Applicant
BD Integrated Diagnostic Solutions/
Becton, Dickinson & Company
7 Loveton Circle
Sparks,  MD  21152
Applicant Contact Kathy Barnecut
Correspondent
BD Integrated Diagnostic Solutions/
Becton, Dickinson & Company
7 Loveton Circle
Sparks,  MD  21152
Correspondent Contact Kathy Barnecut
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Code
QQX  
Date Received04/04/2023
Decision Date 07/31/2023
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
Predetermined Change
Control Plan Authorized		 No
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