510(k) K861284

AP REAGENT CARTRIDGE by Hi Chem, Inc. — Product Code CJE

K861284 is an FDA 510(k) premarket notification submitted by Hi Chem, Inc. for the device "AP REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on April 28, 1986. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Hi Chem, Inc. has at least 10 other 510(k) clearances on record.