510(k) K032535

MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM by Roche Diagnostics Corp. — Product Code DHR

K032535 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 10, 2003. 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.