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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, yeast
510(k) Number K092655
Device Name C. ALBICANS 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 Number866.2660
Classification Product Code
NZS  
Date Received08/28/2009
Decision Date 01/19/2010
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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