Clearance Summary
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 received FDA 510(k) clearance under submission number K051435, sponsored by Clinical Micro Sensors. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2006-01-19.
- Submission: K051435
- Applicant / Sponsor: Clinical Micro Sensors
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5900
- Decision date: 2006-01-19
Classification & Regulation
This clearance is catalogued under FDA product code NUA and 21 CFR 866.5900, within the Immunology review panel as a Class II device.