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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
Applicant Contact mark del vecchio
Correspondent
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
northbrook,  IL  60062
Correspondent 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 (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
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