Clearance Summary
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 received FDA 510(k) clearance under submission number K092868, sponsored by CellaVision AB. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2009-11-20.
- Submission: K092868
- Applicant / Sponsor: CellaVision AB
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 2009-11-20
Classification & Regulation
This clearance is catalogued under FDA product code JOY and 21 CFR 864.5260, within the Hematology review panel as a Class II device.