
Hemodiagnostica, LLC
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SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM is an FDA 510(k)-cleared medical device (K061879) manufactured by Hemodiagnostica, LLC. 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 December 14, 2006. Regulation: 8.