510(k) K241220

Tina-quant Lipoprotein(a) Gen.2 Molarity by Roche Diagnostics Operations — Product Code DFC

K241220 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations for the device "Tina-quant Lipoprotein(a) Gen.2 Molarity". The FDA issued a decision of Substantially Equivalent on January 24, 2025. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. Roche Diagnostics Operations has at least 6 other 510(k) clearances on record.