510(k) K061047

HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 by Hemocue AB — Product Code GKR

K061047 is an FDA 510(k) premarket notification submitted by Hemocue AB for the device "HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801". The FDA issued a decision of Substantially Equivalent on June 8, 2006. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Hemocue AB has at least 10 other 510(k) clearances on record.