
Greiner Bio-One Vacuette North America
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VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES is an FDA 510(k)-cleared medical device (K042927) manufactured by Greiner Bio-One Vacuette North America. 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 April 14, 2005. Regulation: 8.