510(k) K904312

RHEUMAGEN CRP T-CONTROL by Biokit USA, Inc. — Product Code DCK

K904312 is an FDA 510(k) premarket notification submitted by Biokit USA, Inc. for the device "RHEUMAGEN CRP T-CONTROL". The FDA issued a decision of Substantially Equivalent on Oct 1, 1990. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Biokit USA, Inc. has 15 other 510(k) clearances on record.