510(k) K041234

HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM by Hemocue, Inc. — Product Code GKR

K041234 is an FDA 510(k) premarket notification submitted by Hemocue, Inc. for the device "HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 10, 2004. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Hemocue, Inc. has at least 10 other 510(k) clearances on record.