510(k) K984476

LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 by Bio-Rad — Product Code LKO

K984476 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207". The FDA issued a decision of Substantially Equivalent on December 22, 1998. The device falls under product code LKO (Anti-Rnp 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.