Clearance Summary
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 received FDA 510(k) clearance under submission number K062028, sponsored by Celera Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2007-09-07.
- Submission: K062028
- Applicant / Sponsor: Celera Diagnostics
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5900
- Decision date: 2007-09-07
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.