510(k) K072638

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 by Roche Diagnostics Corp. — Product Code JGQ

K072638 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801". The FDA issued a decision of Substantially Equivalent on October 19, 2007. The device falls under product code JGQ (Turbidimetric, Total Protein), a Class II device regulated under 21 CFR 862.1635. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.