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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 K113371
Device Name STAPHYLOCOCCUS QUICKFISH BC
Applicant
ADVANDX, INC.
400 TRADECENTER
SUITE 6990
WOBURN,  MA  01801
Applicant Contact BENJAMIN S CRYSTAL
Correspondent
ADVANDX, INC.
400 TRADECENTER
SUITE 6990
WOBURN,  MA  01801
Correspondent Contact BENJAMIN S CRYSTAL
Regulation Number866.3700
Classification Product Code
NXX  
Date Received11/16/2011
Decision Date 04/03/2012
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
Recalls CDRH Recalls
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