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www.fdanews.com/articles/71848-roche-gets-510-k-for-accu-chek-aviva-blood-glucose-meter

Roche Gets 510(k) for Accu-Chek Aviva Blood Glucose Meter

May 3, 2005

Roche Diagnostics announced that it has received FDA 510(k) clearance for the Accu-Chek Aviva meter, its newest blood glucose meter for the management of diabetes.

The Accu-Chek Aviva provides blood glucose monitoring using only 0.6 microliters of blood. The device offers simple calibration using a snap-in code chip and reviews of past results right on the meter -- a 500-value memory automatically stores results along with times and dates for 7-, 14- and 30-day averages. It also includes an acoustic test reminder and hypoglycemia threshold warning.

The meter will be available in the U.S. market later this year.