Clearance Summary
OMNYX IDP FOR HER2 MANUAL APPLICATION received FDA 510(k) clearance under submission number K131140, sponsored by Omnyx, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2014-04-01.
- Submission: K131140
- Applicant / Sponsor: Omnyx, LLC
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2014-04-01
Classification & Regulation
This clearance is catalogued under FDA product code OEO and 21 CFR 864.1860, within the Hematology review panel as a Class II device.