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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gram-positive bacteria and their resistance markers
510(k) Number K163390
Device Name iC-GPC Assay TM for use on the iC-SystemTM
iCubate, Inc
601 Genome Way
huntsville,  AL  35806
Applicant Contact carter wells
180 Cabot Street
beverly,  MA  01915
Correspondent Contact fran white
Regulation Number866.3365
Classification Product Code
Date Received12/02/2016
Decision Date 08/08/2017
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