510(k) K945655

CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) by Miles, Inc. — Product Code CGX

K945655 is an FDA 510(k) premarket notification submitted by Miles, Inc. for the device "CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)". The FDA issued a decision of Substantially Equivalent on January 5, 1995. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Miles, Inc. has at least 10 other 510(k) clearances on record.