Clearance Summary
GENASIS HIPATH IHC FAMILY received FDA 510(k) clearance under submission number K140957, sponsored by Applied Spectral Imaging , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2015-01-15.
- Submission: K140957
- Applicant / Sponsor: Applied Spectral Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2015-01-15
Classification & Regulation
This clearance is catalogued under FDA product code NQN and 21 CFR 864.1860, within the Hematology review panel as a Class II device.