HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY

HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY is an FDA 510(k)-cleared medical device (K020496) manufactured by Sysmex Corporation of America. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 2002. Regulation: 8.