510(k) K904310

RHEUMAGEN RF T-CONTROL by Biokit USA, Inc. — Product Code DHR

K904310 is an FDA 510(k) premarket notification submitted by Biokit USA, Inc. for the device "RHEUMAGEN RF T-CONTROL". The FDA issued a decision of Substantially Equivalent on May 31, 1991. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Biokit USA, Inc. has at least 10 other 510(k) clearances on record.