510(k) K993971

MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM by Micro Detect, Inc. — Product Code LLL

K993971 is an FDA 510(k) premarket notification submitted by Micro Detect, Inc. for the device "MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM". The FDA issued a decision of Substantially Equivalent on January 11, 2000. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Micro Detect, Inc. has at least 10 other 510(k) clearances on record.