510(k) K884074

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G by Orion Diagnostica, Inc. — Product Code DAH

K884074 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G". The FDA issued a decision of Substantially Equivalent on October 27, 1988. The device falls under product code DAH (Gamma Globulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.