510(k) K061812

COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 by Analyticon Biotechnologies AG — Product Code JIL

K061812 is an FDA 510(k) premarket notification submitted by Analyticon Biotechnologies AG for the device "COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005". The FDA issued a decision of Substantially Equivalent on April 6, 2007. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Analyticon Biotechnologies AG has at least 2 other 510(k) clearances on record.