510(k) K142391

Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) by ACON Laboratories, Inc. — Product Code JFY

K142391 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )". The FDA issued a decision of Substantially Equivalent on December 22, 2014. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.