
Medelec Intl. Corp.
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BLOOD SPECIMEN COLLECTION DEVICES is an FDA 510(k)-cleared medical device (K863491) manufactured by Medelec Intl. 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 23, 1986. Regulation: 8.