Clearance Summary
APERIO EPATHOLOGY EIHC IVD SYSTEM received FDA 510(k) clearance under submission number K141109, sponsored by Leica Biosystems Imaging, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2014-07-29.
- Submission: K141109
- Applicant / Sponsor: Leica Biosystems Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2014-07-29
Classification & Regulation
This clearance is catalogued under FDA product code NOT and 21 CFR 864.1860, within the Hematology review panel as a Class II device.