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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis
510(k) Number K063127
Device Name ENTEROCOCCUS FAECALIS PNA FISH
Applicant
ADVANDX, INC.
690 CANTON STREET, SUITE 302
WESTWOOD,  MA  02090
Applicant Contact Amy Aulwes
Correspondent
ADVANDX, INC.
690 CANTON STREET, SUITE 302
WESTWOOD,  MA  02090
Correspondent Contact Amy Aulwes
Regulation Number866.3740
Classification Product Code
OAH  
Date Received10/13/2006
Decision Date 12/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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