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Home » 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.
KEYWORDS FDAnews Device Daily Bulletin
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