Clearance Summary
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 received FDA 510(k) clearance under submission number K091960, 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 2011-08-29.
- Submission: K091960
- Applicant / Sponsor: Abbott Molecular, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6040
- Decision date: 2011-08-29
Classification & Regulation
This clearance is catalogued under FDA product code OWK and 21 CFR 866.6040, within the Immunology review panel as a Class II device.