510(k) K962452

HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA by Hycor Biomedical, Inc. — Product Code DBM

K962452 is an FDA 510(k) premarket notification submitted by Hycor Biomedical, Inc. for the device "HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA". The FDA issued a decision of Substantially Equivalent on November 25, 1996. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Hycor Biomedical, Inc. has at least 10 other 510(k) clearances on record.