
Harleco
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ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM is an FDA 510(k)-cleared medical device (K780515) manufactured by Harleco. 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 May 18, 1978. Regulation: 8.