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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, genotypic detection, resistant markers, staphylococcus colonies
510(k) Number K140619
Device Name MECA XPRESSFISH
Applicant
ADVANDX, INC.
400 TradeCenter Suite 6990
woburn,  MA  01801
Applicant Contact ron eisenwinter
Correspondent
ADVANDX, INC.
400 TradeCenter Suite 6990
woburn,  MA  01801
Correspondent Contact ron eisenwinter
Regulation Number866.1640
Classification Product Code
MYI  
Date Received03/11/2014
Decision Date 10/10/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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