510(k) K872237

KALLESTAD QM300 IGM ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code DFT

K872237 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "KALLESTAD QM300 IGM ANTIBODY PACK". The FDA issued a decision of Substantially Equivalent on July 9, 1987. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.