AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)

AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) is an FDA 510(k)-cleared medical device (K875346) manufactured by Contraves Medical Instruments, Inc.. 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 6, 1988. Regulation: 8.