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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 K092784
Device Name C. ALBICANS/C. GLABRATA PNA FISH
Applicant
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Applicant Contact henrik stender
Correspondent
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Correspondent Contact henrik stender
Regulation Number866.2660
Classification Product Code
NZS  
Date Received09/10/2009
Decision Date 03/12/2010
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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