510(k) K122177

ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL by Elitechgroup — Product Code JIT

K122177 is an FDA 510(k) premarket notification submitted by Elitechgroup for the device "ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL". The FDA issued a decision of Substantially Equivalent on February 15, 2013. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Elitechgroup has at least 10 other 510(k) clearances on record.