510(k) K984479

LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 by Bio-Rad — Product Code LKP

K984479 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208". The FDA issued a decision of Substantially Equivalent on December 22, 1998. The device falls under product code LKP (Anti-Sm Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Bio-Rad has at least 10 other 510(k) clearances on record.