LXN CORP.'S FRUCTOSAMINE MONITOR MAY REQUIRE PRESCRIPTION FOR HOME USE -- FDA PANEL; 510(K) SUPPORTS SUBSTANTIAL EQUIVALENCE TO LAB-USE DEVICE, GROUP AGREES
This article was originally published in The Gray Sheet
Executive Summary
FDA is considering requiring a prescription for home use of LXN Corporation's blood fructosamine monitor for diabetics. Members of FDA's Clinical Chemistry and Clinical Toxicology Devices Panel voiced their support for such a requirement at a March 20 meeting in Gaithersburg, Maryland.
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