510(k) K953927

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

K953927 is an FDA 510(k) premarket notification submitted by International Enzymes, Inc. for the device "LINICAL PROTEIN VI 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 DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. International Enzymes, Inc. has at least 6 other 510(k) clearances on record.