510(k) K810226

SLE ANTI-N-DNA LATEX TEST by Icl Scientific — Product Code DHC

K810226 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "SLE ANTI-N-DNA LATEX TEST". The FDA issued a decision of Substantially Equivalent on February 9, 1981. The device falls under product code DHC (System, Test, Systemic Lupus Erythematosus), a Class II device regulated under 21 CFR 866.5820. Icl Scientific has at least 10 other 510(k) clearances on record.