Clearance Summary
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 received FDA 510(k) clearance under submission number K100015, sponsored by Abbott Molecular, 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 2011-08-09.
- Submission: K100015
- Applicant / Sponsor: Abbott Molecular, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6040
- Decision date: 2011-08-09
Classification & Regulation
This clearance is catalogued under FDA product code OVQ and 21 CFR 866.6040, within the Immunology review panel as a Class II device.