510(k) K896922

RAICHEM TM HEMOGLOBIN REAGENT by Reagents Applications, Inc. — Product Code GKK

K896922 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "RAICHEM TM HEMOGLOBIN REAGENT". The FDA issued a decision of Substantially Equivalent on January 25, 1990. The device falls under product code GKK (Cyanomethemoglobin), a Class II device regulated under 21 CFR 864.7500. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.