Clearance Summary
OC-SENSOR DIANA IFOB TEST received FDA 510(k) clearance under submission number K092330, sponsored by Polymedco Cancer Diagnostics, 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 2010-01-08.
- Submission: K092330
- Applicant / Sponsor: Polymedco Cancer Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 2010-01-08
Classification & Regulation
This clearance is catalogued under FDA product code OOX and 21 CFR 864.6550, within the Hematology review panel as a Class II device.