Clearance Summary
VYSIS D7S486/CEP 7 FISH PROBE KIT received FDA 510(k) clearance under submission number K131508, sponsored by Abbott Molecular, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2013-09-13.
- Submission: K131508
- Applicant / Sponsor: Abbott Molecular, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1870
- Decision date: 2013-09-13
Classification & Regulation
This clearance is catalogued under FDA product code PFG and 21 CFR 864.1870, within the Hematology review panel as a Class II device.