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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name c.difficile toxin gene amplification assay
510(k) Number K132235
Device Name IMDX C.DIFFICILE FOR ABBOTT M2000
Original Applicant
Intelligent Medical Devices, Inc.
180 cabot st
beverly,  MA  01915
Original Contact fran white
Regulation Number866.3130
Classification Product Code
OZN  
Subsequent Product Code
OOI  
Date Received07/18/2013
Decision Date 10/11/2013
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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