510(k) K012359

TINA-QUANT COMPLEMENT C4 TEST SYSTEM by Roche Diagnostics Corp. — Product Code DBI

K012359 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT COMPLEMENT C4 TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 2001. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.