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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, Enterococcus Faecalis
510(k) Number K121991
Device Name ENTEROCOCCUS 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 Number866.3740
Classification Product Code
OAH  
Date Received07/06/2012
Decision Date 01/07/2013
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
Predetermined Change
Control Plan Authorized		 No
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