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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, identification, yeast
510(k) Number K062461
Device Name C. ALBICANS PNA FISH
Applicant
ADVANDX, INC.
690 CANTON STREET, SUITE 302
WESTWOOD,  MA  02090
Applicant Contact Amy Aulwes
Correspondent
ADVANDX, INC.
690 CANTON STREET, SUITE 302
WESTWOOD,  MA  02090
Correspondent Contact Amy Aulwes
Regulation Number866.2660
Classification Product Code
JXB  
Subsequent Product Code
NZS  
Date Received08/23/2006
Decision Date 10/25/2006
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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