
Triangle Biomedical Sciences, Inc.
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MICRO21 WITH WBC ESTIMATE is an FDA 510(k)-cleared medical device (K973050) manufactured by Triangle Biomedical Sciences, 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 November 6, 1997. Regulation: 8.