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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K142033
Device Name VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
Applicant
NANOSPERE,INC.
4088 COMMERCIAL AVE
NORTHBROOK,  IL  60062
Applicant Contact NOAH LERMER
Correspondent
NANOSPERE,INC.
4088 COMMERCIAL AVE
NORTHBROOK,  IL  60062
Correspondent Contact NOAH LERMER
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Codes
OOI   PCI  
Date Received07/25/2014
Decision Date 10/10/2014
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
Recalls CDRH Recalls
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