510(k) K910745

HEMOGLOBIN REAGENT by Toa Medical Electronics USA, Inc. — Product Code GKR

K910745 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "HEMOGLOBIN REAGENT". The FDA issued a decision of Substantially Equivalent on July 11, 1991. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Toa Medical Electronics USA, Inc. has at least 10 other 510(k) clearances on record.