
Elitechgroup
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ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL is an FDA 510(k)-cleared medical device (K122177) manufactured by Elitechgroup. 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 February 14, 2013. Regulation: 8.