510(k) K954831

ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY by Orgentec — Product Code LKO

K954831 is an FDA 510(k) premarket notification submitted by Orgentec for the device "ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY". The FDA issued a decision of Substantially Equivalent on May 8, 1996. The device falls under product code LKO (Anti-Rnp Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Orgentec has at least 9 other 510(k) clearances on record.