Clearance Summary
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION received FDA 510(k) clearance under submission number K874207, sponsored by Intl. Remote Imaging Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1988-01-05.
- Submission: K874207
- Applicant / Sponsor: Intl. Remote Imaging Systems
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3600
- Decision date: 1988-01-05
Classification & Regulation
This clearance is catalogued under FDA product code IBJ and 21 CFR 864.3600, within the Pathology review panel as a Class I device.