510(k) K024227

LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 by Bio-Rad — Product Code DHN

K024227 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127". The FDA issued a decision of Substantially Equivalent on January 15, 2003. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Bio-Rad has at least 10 other 510(k) clearances on record.