510(k) K193047

N Latex FLC kappa, N Latex FLC lambda by Siemens Healthcare Diagnostics Products GmbH — Product Code DFH

K193047 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products GmbH for the device "N Latex FLC kappa, N Latex FLC lambda". The FDA issued a decision of Substantially Equivalent on July 14, 2021. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Siemens Healthcare Diagnostics Products GmbH has at least 10 other 510(k) clearances on record.