510(k) K971817

OLYMPUS CK-MB REAGENT by Olympus America, Inc. — Product Code JLB

K971817 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS CK-MB REAGENT". The FDA issued a decision of Substantially Equivalent on June 11, 1997. The device falls under product code JLB (Atp And Creatine Kinase (Enzymatic), Creatine), a Class I device regulated under 21 CFR 862.1210. Olympus America, Inc. has at least 10 other 510(k) clearances on record.