510(k) K891061

BIOTROL CALCIUM MONOREACTIF by Biotrol, USA, Inc. — Product Code CJY

K891061 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL CALCIUM MONOREACTIF". The FDA issued a decision of Substantially Equivalent on August 10, 1989. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.