510(k) K811714

HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT by Scripps-Miles, Inc. — Product Code DHN

K811714 is an FDA 510(k) premarket notification submitted by Scripps-Miles, Inc. for the device "HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Scripps-Miles, Inc. has at least 8 other 510(k) clearances on record.