510(k) K822607

ANTINUCLEAR ANTOBODY CELL SUBSTRATE by Immulok, Inc. — Product Code DHN

K822607 is an FDA 510(k) premarket notification submitted by Immulok, Inc. for the device "ANTINUCLEAR ANTOBODY CELL SUBSTRATE". The FDA issued a decision of Substantially Equivalent on September 17, 1982. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Immulok, Inc. has at least 10 other 510(k) clearances on record.