510(k) K881742

BIOTROL ALKALINE PHOSPHATASE by Biotrol, USA, Inc. — Product Code CJE

K881742 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL ALKALINE PHOSPHATASE". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.