
Nova Biomedical Corp.
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STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS is an FDA 510(k)-cleared medical device (K981426) manufactured by Nova Biomedical 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 May 11, 1998. Regulation: 8.