510(k) K060765

HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 by Hemocue AB — Product Code LFR

K060765 is an FDA 510(k) premarket notification submitted by Hemocue AB for the device "HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712". The FDA issued a decision of Substantially Equivalent on September 6, 2006. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Hemocue AB has at least 10 other 510(k) clearances on record.