510(k) K905683

BIOTROL LACTATE DEHYDROGENASE (L-P) by Biotrol, USA, Inc. — Product Code CFJ

K905683 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL LACTATE DEHYDROGENASE (L-P)". The FDA issued a decision of Substantially Equivalent on March 11, 1991. The device falls under product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.