510(k) K953598

SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS by Serono Diagnostics, Inc. — Product Code GKZ

K953598 is an FDA 510(k) premarket notification submitted by Serono Diagnostics, Inc. for the device "SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS". The FDA issued a decision of Substantially Equivalent on March 11, 1996. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Serono Diagnostics, Inc. has at least 10 other 510(k) clearances on record.