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Biotest Medizintechnik GmbH
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BIOTEST HEMOGLOBIN MEASURING SYSTEM is an FDA 510(k)-cleared medical device (K020710) manufactured by Biotest Medizintechnik GmbH. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2002. Regulation: 8.