Clearance Summary
WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER received FDA 510(k) clearance under submission number K953116, sponsored by Intl. Remote Imaging Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1996-05-13.
- Submission: K953116
- Applicant / Sponsor: Intl. Remote Imaging Systems
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 1996-05-13
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.