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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, genotypic detection, resistant markers, enterococcus species
510(k) Number K102416
Device Name BD GENEOHM VANR ASSAY
Applicant
BD DIAGNOSTICS SCIENCE
7 LOVETON CIRCLE
MAIL CODE 614
SPARKS,  MD  21152
Applicant Contact RAYMOND BOULE
Correspondent
BD DIAGNOSTICS SCIENCE
7 LOVETON CIRCLE
MAIL CODE 614
SPARKS,  MD  21152
Correspondent Contact RAYMOND BOULE
Regulation Number866.1640
Classification Product Code
NIJ  
Date Received08/24/2010
Decision Date 10/20/2011
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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