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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C. Difficile Toxin Gene Amplification Assay
510(k) Number K123197
Device Name VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
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 Number866.3130
Classification Product Code
OZN  
Date Received10/11/2012
Decision Date 12/05/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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