510(k) K944513

LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E by International Enzymes, Inc. — Product Code JJY

K944513 is an FDA 510(k) premarket notification submitted by International Enzymes, Inc. for the device "LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E". The FDA issued a decision of Substantially Equivalent on December 2, 1994. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. International Enzymes, Inc. has at least 6 other 510(k) clearances on record.