Clearance Summary
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING received FDA 510(k) clearance under submission number K093974, sponsored by Osmetech Molecular Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2010-04-22.
- Submission: K093974
- Applicant / Sponsor: Osmetech Molecular Diagnostics
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7280
- Decision date: 2010-04-22
Classification & Regulation
This clearance is catalogued under FDA product code NPQ and 21 CFR 864.7280, within the Hematology review panel as a Class II device.