510(k) K071239

TOTAL PROTEIN URINE/CSF GEN.3 by Roche Diagnostics — Product Code JGQ

K071239 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "TOTAL PROTEIN URINE/CSF GEN.3". The FDA issued a decision of Substantially Equivalent on September 14, 2007. The device falls under product code JGQ (Turbidimetric, Total Protein), a Class II device regulated under 21 CFR 862.1635. Roche Diagnostics has at least 10 other 510(k) clearances on record.