Clearance Summary
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 received FDA 510(k) clearance under submission number K080909, sponsored by Ikonisys, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2008-10-17.
- Submission: K080909
- Applicant / Sponsor: Ikonisys, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.4700
- Decision date: 2008-10-17
Classification & Regulation
This clearance is catalogued under FDA product code NTH and 21 CFR 866.4700, within the Immunology review panel as a Class II device.