510(k) K872599

QM300 C4 ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code DBI

K872599 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "QM300 C4 ANTIBODY PACK". The FDA issued a decision of Substantially Equivalent on July 23, 1987. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.