510(k) K990915

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY by Stellar Bio Systems, Inc. — Product Code DHN

K990915 is an FDA 510(k) premarket notification submitted by Stellar Bio Systems, Inc. for the device "INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY". The FDA issued a decision of Substantially Equivalent on April 21, 1999. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Stellar Bio Systems, Inc. has at least 6 other 510(k) clearances on record.