Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT007827

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel