510(k) K101203

TINA-QUANT ALBUMIN GEN 2 by Roche Diagnostics — Product Code DCF

K101203 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "TINA-QUANT ALBUMIN GEN 2". The FDA issued a decision of Substantially Equivalent on September 10, 2010. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Roche Diagnostics has at least 10 other 510(k) clearances on record.