510(k) K934013

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT by Isolab, Inc. — Product Code CIN

K934013 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Isolab, Inc. has at least 10 other 510(k) clearances on record.