Clearance Summary
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 received FDA 510(k) clearance under submission number K090901, sponsored by Osmetech Molecular 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 2009-07-06.
- Submission: K090901
- Applicant / Sponsor: Osmetech Molecular Diagnostics
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5900
- Decision date: 2009-07-06
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.