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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 K091827
Device Name S. AUREUS PNA FISH
Applicant
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Contact paula e burger
Regulation Number866.3700
Classification Product Code
NXX  
Date Received06/19/2009
Decision Date 08/18/2009
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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