
Primus Corp.
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PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 is an FDA 510(k)-cleared medical device (K994045) manufactured by Primus 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 December 20, 1999. Regulation: 8.