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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 K071026
Device Name BD GENEOHM STAPHSR ASSAY
Original Applicant
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
6146 nancy ridge drive
san diego,  CA  92121
Original Contact raymond boule
Regulation Number866.1640
Classification Product Code
NQX  
Date Received04/11/2007
Decision Date 12/20/2007
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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