510(k) K955133

ORGENTEC ENASCREEN PIN IMMUNO ASSAY by Orgentec — Product Code LLL

K955133 is an FDA 510(k) premarket notification submitted by Orgentec for the device "ORGENTEC ENASCREEN PIN IMMUNO ASSAY". The FDA issued a decision of Substantially Equivalent on March 20, 1996. The device falls under product code LLL (Extractable Antinuclear 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.