FDA 510(k) Application Details - K163390

Device Classification Name	More FDA Info for this Device
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 US Other 510(k) Applications for this Company
Contact	Carter Wells Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2016
Decision Date	08/08/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review