510(k) K872717

QM300 HAPTOGLOBIN ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code DAD

K872717 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "QM300 HAPTOGLOBIN ANTIBODY PACK". The FDA issued a decision of Substantially Equivalent on July 21, 1987. The device falls under product code DAD (Haptoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5460. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.