Clearance Summary
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM received FDA 510(k) clearance under submission number DEN040001, sponsored by Advanced Diagnostic Systems. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2004-01-21.
- Submission: DEN040001
- Applicant / Sponsor: Advanced Diagnostic Systems
- Clearance pathway: Post-NSE
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6020
- Decision date: 2004-01-21
Classification & Regulation
This clearance is catalogued under FDA product code NQI and 21 CFR 866.6020, within the Immunology review panel as a Class II device.