Clearance Summary
Philips IntelliSite Pathology Solution received FDA 510(k) clearance under submission number K203845, sponsored by Philips Medical Systems Nederland B.V.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2021-09-17.
- Submission: K203845
- Applicant / Sponsor: Philips Medical Systems Nederland B.V.
- Clearance pathway: Abbreviated
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2021-09-17
Classification & Regulation
This clearance is catalogued under FDA product code PSY and 21 CFR 864.3700, within the Pathology review panel as a Class II device.