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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
Models REF 441769, REF 441772
Device Name BD MAX GBS ASSAY, BD MAX INSTRUMENT
Applicant
BECTON DICKINSON & CO.
7 loveton cir.
baltimore,  MD  21152
Contact mary anne williams
Regulation Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received07/05/2011
Decision Date 02/16/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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