510(k) K852027

GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER by Advanced Biomedical Methods, Inc. — Product Code DKJ

K852027 is an FDA 510(k) premarket notification submitted by Advanced Biomedical Methods, Inc. for the device "GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER". The FDA issued a decision of Substantially Equivalent on May 29, 1985. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. Advanced Biomedical Methods, Inc. has at least 10 other 510(k) clearances on record.