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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 K181427
Device Name BD MAX Enteric Viral Panel, BD MAX Instrument
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Applicant Contact Laura Stewart
Correspondent
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Correspondent Contact Laura Stewart
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Code
OOI  
Date Received06/01/2018
Decision Date 11/29/2018
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
Recalls CDRH Recalls
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