510(k) K800820

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY by Calbiochem-Behring Corp. — Product Code DBE

K800820 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY". The FDA issued a decision of Substantially Equivalent on April 24, 1980. The device falls under product code DBE (Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5120. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.