
Nova Biomedical Corp.
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NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS is an FDA 510(k)-cleared medical device (K070068) manufactured by Nova Biomedical Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 6, 2007. Regulation: 8.