510(k) K912551

ANTI-ENDOMYSIAL ANTIBODY TEST by Immco Diagnostics, Inc. — Product Code DBL

K912551 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "ANTI-ENDOMYSIAL ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on June 9, 1993. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.