510(k) K894538

QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code DBN

K894538 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK". The FDA issued a decision of Substantially Equivalent on August 4, 1989. The device falls under product code DBN (Fc, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5530. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.