510(k) K891907

QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED by R&D Systems, Inc. — Product Code JCN

K891907 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED". The FDA issued a decision of Substantially Equivalent on April 11, 1989. The device falls under product code JCN (Control, Cell Counter, Normal And Abnormal), a Class II device regulated under 21 CFR 864.8625. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.