510(k) K183432

cobas u 601 urinalysis test system by Roche Diagnostics — Product Code JIL

K183432 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "cobas u 601 urinalysis test system". The FDA issued a decision of Substantially Equivalent on May 7, 2019. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Roche Diagnostics has at least 10 other 510(k) clearances on record.