
Heraeus Kulzer, Inc.
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GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM is an FDA 510(k)-cleared medical device (K904081) manufactured by Heraeus Kulzer, Inc.. 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 December 25, 1990. Regulation: 8.