Clearance Summary
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 received FDA 510(k) clearance under submission number K153150, sponsored by Inova Diagnostics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2015-11-24.
- Submission: K153150
- Applicant / Sponsor: Inova Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.4750
- Decision date: 2015-11-24
Classification & Regulation
This clearance is catalogued under FDA product code PIV and 21 CFR 866.4750, within the Immunology review panel as a Class II device.