510(k) K000534

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II by Roche Diagnostics Corp. — Product Code DHR

K000534 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II". The FDA issued a decision of Substantially Equivalent on April 5, 2000. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.