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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastrointestinal pathogen panel multiplex nucleic acid-based assay system
510(k) Number K220607
Device Name BD MAX Enteric Viral Panel
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Applicant Contact Joseph Basore
Correspondent
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Correspondent Contact Mark Sistare
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Code
OOI  
Date Received03/02/2022
Decision Date 09/21/2022
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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