ARKRAY USA Receives FDA Clearance On GLUCOCARD(TM) 01 Blood Glucose Monitoring System

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices
Article Date: 28 Jun 2008 - 0:00 PDT

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ARKRAY USA, Inc. announced 510(k) clearance on GLUCOCARD(TM) 01 Blood Glucose Monitoring System.

GLUCOCARD(TM) 01

This new, affordable system requires no coding, displays results in 7 seconds, and requires a tiny 0.3 microliter sample size. GLUCOCARD(TM) 01 is AST approved and has a 360-count test memory with time and date stamp. It also features a large, easy-to-read display for better viewing of test results. The GLUCOCARD(TM) 01 is distinguished by its leading edge design and technology. Recent clinical data showed GLUCOCARD(TM) 01 to be highly accurate.

"ARKRAY is excited to announce a new addition to our growing line of GLUCOCARD(TM) blood glucose monitoring systems. The novel GLUCOCARD(TM) 01 system follows the GLUCOCARD(TM) brand image of sleek, compact, and discreet. The GLUCOCARD(TM) 01 appearance is similar to leading cell phone designs and unlike other glucose monitors on the market," said Jonathan Chapman, President of ARKRAY USA, Inc. "We look forward to building off the GLUCOCARD(TM) 01 technology and launching further systems later this year that will utilize the identical test strip."

About ARKRAY USA

ARKRAY has been a pioneer for nearly 50 years in the field of automated analysis from laboratory and point-of-care systems to home use patient self-testing systems. ARKRAY's primary focus throughout that time has been diabetes, developing the world's first hand held blood glucose meter (late 1960s) and the world's first HbA1c analyzer (1982). ARKRAY is one of the few diabetes testing companies in the US market today that undertakes in-house each step of the development process to bring products to market. ARKRAY is among the leading medical device companies noted for their patent-based intellectual property by Patent Board (Wall Street Journal 6/17/08). Worldwide, ARKRAY is the 5th largest blood glucose meter manufacturer.

ARKRAY USA
http://www.arkrayusa.com