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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrumentation for clinical multiplex test systems
510(k) Number K070597
Device Name VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
Applicant
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
northbrook,  IL  60062
Applicant Contact sue kent
Correspondent
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
northbrook,  IL  60062
Correspondent Contact sue kent
Regulation Number862.2570
Classification Product Code
NSU  
Subsequent Product Codes
NPQ   NPR   OMM  
Date Received03/02/2007
Decision Date 10/11/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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