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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
510(k) Number K120138
Device Name BD MAX MRSA ASSAY, BD MAX INSTRUMENT
Original Applicant
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
7 loveton circle,
mail code 614
sparks,  MD  21152
Original Contact raymond j boule
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received01/17/2012
Decision Date 07/05/2012
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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