510(k) K871940

QM300 IGA, ANTIGEN, ANTISERUM, CONTROL by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code CZP

K871940 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "QM300 IGA, ANTIGEN, ANTISERUM, CONTROL". The FDA issued a decision of Substantially Equivalent on June 12, 1987. The device falls under product code CZP (Iga, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.