Clearance Summary
iC-GPC Assay TM for use on the iC-SystemTM received FDA 510(k) clearance under submission number K163390, sponsored by Icubate, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2017-08-08.
- Submission: K163390
- Applicant / Sponsor: Icubate, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3365
- Decision date: 2017-08-08
Classification & Regulation
This clearance is catalogued under FDA product code PAM and 21 CFR 866.3365, within the Microbiology review panel as a Class II device.