
Statspin Technologies
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STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES is an FDA 510(k)-cleared medical device (K903698) manufactured by Statspin Technologies. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 1990. Regulation: 8.