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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, enterobacteriaceae
510(k) Number K123418
Device Name GRAM-NEGATIVE 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 Number866.2660
Classification Product Code
JSS  
Date Received11/06/2012
Decision Date 07/21/2013
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
Recalls CDRH Recalls
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