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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K214122
Device Name BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial 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 Joseph Basore
Regulation Number866.3990
Classification Product Code
PCI  
Subsequent Product Codes
OOI   PCH  
Date Received12/30/2021
Decision Date 07/28/2022
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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