
Incstar Corp.
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EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) is an FDA 510(k)-cleared medical device (K902639) manufactured by Incstar Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 1990. Regulation: 8.