Clearance Summary
CYTOSCAN received FDA 510(k) clearance under submission number K864955, sponsored by Image Recognition Systems , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1987-03-16.
- Submission: K864955
- Applicant / Sponsor: Image Recognition Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 1987-03-16
Classification & Regulation
This clearance is catalogued under FDA product code LNJ and 21 CFR 864.5260, within the Hematology review panel as a Class II device.