The concept of substantial equivalence, introduced for the risk assessment of genetically modified (GM) food, is a reducing concept because it ignores the context in which these products have been produced and brought to the consumer at the end of the food chain. Food quality cannot be restricted to mere substance and food acts on human beings not only at the level of nutrition but also through...

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...