510(k) K214068

Quantia IgE by Biokit, S.A. — Product Code DGC

K214068 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "Quantia IgE". The FDA issued a decision of Substantially Equivalent on February 21, 2023. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Biokit, S.A. has at least 10 other 510(k) clearances on record.