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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, enterococcus species
510(k) Number K123753
Device Name IMDX VANR FOR ABBOTT M2000
Applicant
INTELLIGENT MEDICAL DEVICES, INC
180 CABOT ST.
BEVERLY,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
INTELLIGENT MEDICAL DEVICES, INC
180 CABOT ST.
BEVERLY,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.1640
Classification Product Code
NIJ  
Subsequent Product Code
OOI  
Date Received12/06/2012
Decision Date 07/17/2013
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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