
Nova Biomedical Corp.
Free shipping on orders over $99 · 30-day returns
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS is an FDA 510(k)-cleared medical device (K961938) 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 June 27, 1996. Regulation: 8.