510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

A. 510(k) Number: k093974 B. Purpose for Submission: New Device C. Measurand: Factor II (FII) (Prothrombin) Factor V (FV) Leiden 5, 10 methylenetetrahydrofolate reductase (MTHFR) D. Type of Test: Qualitative genotyping test for single nucleotide polymorphism detection E. Applicant: Osmetech Molecular Diagnostics F. Proprietary and Established Names: eSensor® Thrombophilia Risk Test eSensor® FII...