
Elitechgroup Vital Scientific BV
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ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... is an FDA 510(k)-cleared medical device (K102647) manufactured by Elitechgroup Vital Scientific BV. 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 March 23, 2011. Regulation: 8.