510(k) K040435

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 by Roche Diagnostics Corp. — Product Code CZP

K040435 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2". The FDA issued a decision of Substantially Equivalent on March 10, 2004. The device falls under product code CZP (Iga, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.