510(k) K032203

HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 by Hemocue, Inc. — Product Code GKR

K032203 is an FDA 510(k) premarket notification submitted by Hemocue, Inc. for the device "HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704". The FDA issued a decision of Substantially Equivalent on August 25, 2003. 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.