510(k) K132399

ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL by Elitechgroup — Product Code JFY

K132399 is an FDA 510(k) premarket notification submitted by Elitechgroup for the device "ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL". The FDA issued a decision of Substantially Equivalent on January 3, 2014. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Elitechgroup has at least 10 other 510(k) clearances on record.