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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nucleic acid amplification assay system, group b streptococcus, direct specimen test
510(k) Number K111860
Device Name BD MAX GBS ASSAY, BD MAX INSTRUMENT
Applicant
BECTON DICKINSON & CO.
7 LOVETON CIR.
BALTIMORE,  MD  21152
Applicant Contact MARY ANNE WILLIAMS
Correspondent
BECTON DICKINSON & CO.
7 LOVETON CIR.
BALTIMORE,  MD  21152
Correspondent Contact MARY ANNE WILLIAMS
Regulation Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received06/30/2011
Decision Date 02/16/2012
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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