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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
Model KT005
Device Name S. AUREUS/CNS PNA FISH, MODEL KT005
Applicant
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Contact paula e bulger
Regulation Number866.3700
Classification Product Code
NXX  
Date Received07/21/2009
Decision Date 11/23/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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