510(k) K022944

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA by Hycor Biomedical, Inc. — Product Code MSV

K022944 is an FDA 510(k) premarket notification submitted by Hycor Biomedical, Inc. for the device "AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA". The FDA issued a decision of Substantially Equivalent on December 18, 2002. 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. Hycor Biomedical, Inc. has at least 10 other 510(k) clearances on record.