
Orhto Diagnostic Systems, Inc.
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ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW is an FDA 510(k)-cleared medical device (K820401) manufactured by Orhto Diagnostic Systems, 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 March 14, 1982. Regulation: 8.