ABX PENTRA 60 HEMATOLOGY ANALYZER

ABX PENTRA 60 HEMATOLOGY ANALYZER is an FDA 510(k)-cleared medical device (K992511) manufactured by Abx Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 1999. Regulation: 8.