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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
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