
Primus, Inc.
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NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY is an FDA 510(k)-cleared medical device (K993131) manufactured by Primus, 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 May 21, 2000. Regulation: 8.