510(k) K030702

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA by Immco Diagnostics, Inc. — Product Code MSV

K030702 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA". The FDA issued a decision of Substantially Equivalent on September 9, 2003. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.