Clearance Summary
BANDVIEW SYSTEM received FDA 510(k) clearance under submission number K012103, 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 2001-09-14.
- Submission: K012103
- Applicant / Sponsor: Applied Spectral Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 2001-09-14
Classification & Regulation
This clearance is catalogued under FDA product code LNJ and 21 CFR 864.5260, within the Hematology review panel as a Class II device.