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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 K082612
Device Name GBS PNA FISH
Applicant
ADVANDX, INC.
10A ROESSLER ROAD
woburn,  MA  01801
Applicant Contact paula e bulger
Correspondent
ADVANDX, INC.
10A ROESSLER ROAD
woburn,  MA  01801
Correspondent Contact paula e bulger
Regulation Number866.3740
Classification Product Code
OAH  
Date Received09/09/2008
Decision Date 05/05/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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