510(k) K953495

EIA KIT FOR THE DETECTION OF GBM ANTIBODIES by Scimedx Corp. — Product Code DBL

K953495 is an FDA 510(k) premarket notification submitted by Scimedx Corp. for the device "EIA KIT FOR THE DETECTION OF GBM ANTIBODIES". The FDA issued a decision of Substantially Equivalent on April 10, 1996. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Scimedx Corp. has at least 10 other 510(k) clearances on record.