
Worthington Diagnostic Systems
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COMPUR* M1100 HEMATRCRIT SYSTEM is an FDA 510(k)-cleared medical device (K831318) manufactured by Worthington Diagnostic Systems. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 1983. Regulation: 8.