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Icubate, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K190341
iC-GN iC-Cassette for use on the iC-System
June 28, 2019
K163390
iC-GPC Assay TM for use on the iC-SystemTM
August 8, 2017