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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gram-negative bacteria and associated resistance markers
510(k) Number K190341
Device Name iC-GN iC-Cassette for use on the iC-System
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
PEN  
Date Received02/14/2019
Decision Date 06/28/2019
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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