Clearance Summary
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE received FDA 510(k) clearance under submission number K962873, sponsored by Vysis. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1997-01-13.
- Submission: K962873
- Applicant / Sponsor: Vysis
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6040
- Decision date: 1997-01-13
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.