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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 K112424
Device Name VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
Applicant
NANOSPHERE, INC
4088 commercial avenue
northbrook,  IL  60062
Contact mark del vecchio
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
NSU  
Date Received08/23/2011
Decision Date 12/16/2011
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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