510(k) K914025

TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) by Technicon Instruments Corp. — Product Code CIT

K914025 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)". The FDA issued a decision of Substantially Equivalent on November 22, 1991. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.