510(k) K812912

GILCHEM ALP REAGENT by Gilford Diagnostics — Product Code CJE

K812912 is an FDA 510(k) premarket notification submitted by Gilford Diagnostics for the device "GILCHEM ALP REAGENT". The FDA issued a decision of Substantially Equivalent on November 2, 1981. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Gilford Diagnostics has at least 10 other 510(k) clearances on record.