510(k) K885227

CLINISTAT HEMOGLOBIN REAGENT TEST by Heraeus Kulzer, Inc. — Product Code KHG

K885227 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "CLINISTAT HEMOGLOBIN REAGENT TEST". The FDA issued a decision of Substantially Equivalent on February 24, 1989. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Heraeus Kulzer, Inc. has at least 10 other 510(k) clearances on record.