510(k) K926569

IMMUNO RA UNDILUTED by Immunostics Co., Inc. — Product Code DHR

K926569 is an FDA 510(k) premarket notification submitted by Immunostics Co., Inc. for the device "IMMUNO RA UNDILUTED". The FDA issued a decision of Substantially Equivalent on April 6, 1993. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Immunostics Co., Inc. has at least 10 other 510(k) clearances on record.