510(k) K893896

QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA by Biostar Medical Products, Inc. — Product Code LKJ

K893896 is an FDA 510(k) premarket notification submitted by Biostar Medical Products, Inc. for the device "QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Biostar Medical Products, Inc. has at least 4 other 510(k) clearances on record.