Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact