
Ortho Diagnostic Systems, Inc.
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ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA is an FDA 510(k)-cleared medical device (K902210) manufactured by Ortho 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 July 2, 1990. Regulation: 8.