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FDA 510(k) Applications Submitted by Carter Wells
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190341
02/14/2019
iC-GN iC-Cassette for use on the iC-System
iCubate, Inc.
K163390
12/02/2016
iC-GPC Assay TM for use on the iC-SystemTM
iCubate, Inc
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