510(k) K930757

RHEUMELISA II JO-1 ANTIBODY TEST KIT by Biowhittaker Molecular Applications, Inc. — Product Code LLL

K930757 is an FDA 510(k) premarket notification submitted by Biowhittaker Molecular Applications, Inc. for the device "RHEUMELISA II JO-1 ANTIBODY TEST KIT". The FDA issued a decision of Substantially Equivalent on March 26, 1993. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Biowhittaker Molecular Applications, Inc. has at least 9 other 510(k) clearances on record.