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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
Applicant
iCubate, Inc
601 Genome Way
huntsville,  AL  35806
Applicant Contact carter wells
Correspondent
MDC ASSOCIATES, LLC
180 Cabot Street
beverly,  MA  01915
Correspondent Contact fran white
Regulation Number866.3365
Classification Product Code
PAM  
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
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