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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K143653
Device Name Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
Applicant
Nanosphere, Inc.
4088 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact Noah Lermer
Correspondent
MDC Associates, LLC
180 Cabot St.
Beverly,  MA  01915
Correspondent Contact Fran White
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP   OOI   OOU   OZE  
OZZ  
Date Received12/23/2014
Decision Date 09/04/2015
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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