510(k) K902462

MODIFIED QM300 RHEUMATOID FACTOR TEST by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code DHR

K902462 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "MODIFIED QM300 RHEUMATOID FACTOR TEST". The FDA issued a decision of Substantially Equivalent on June 21, 1990. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.