510(k) K972456

RHEUMACOL RHEUMATOID FACTOR TEST by Immunostics Inc., — Product Code DHR

K972456 is an FDA 510(k) premarket notification submitted by Immunostics Inc., for the device "RHEUMACOL RHEUMATOID FACTOR TEST". The FDA issued a decision of Substantially Equivalent on November 25, 1997. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Immunostics Inc., has at least 10 other 510(k) clearances on record.