510(k) K953926

LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM by International Enzymes, Inc. — Product Code DCK

K953926 is an FDA 510(k) premarket notification submitted by International Enzymes, Inc. for the device "LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. International Enzymes, Inc. has at least 6 other 510(k) clearances on record.