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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, rna, staphylococcus aureus
510(k) Number K092166
Device Name S. AUREUS/CNS PNA FISH, MODEL KT005
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 Number866.3700
Classification Product Code
NXX  
Date Received07/21/2009
Decision Date 11/23/2009
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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