510(k) K861167

IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST by Atlantic Antibodies — Product Code CZP

K861167 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST". The FDA issued a decision of Substantially Equivalent on April 25, 1986. The device falls under product code CZP (Iga, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Atlantic Antibodies has at least 10 other 510(k) clearances on record.