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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
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