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Biocare Corp.
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BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER is an FDA 510(k)-cleared medical device (K002855) manufactured by Biocare 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 October 11, 2000. Regulation: 8.