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Runbio Biotech Co.,Ltd
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DAVID PREGNANCY TEST (MIDSTREAM) is an FDA 510(k)-cleared medical device (K053236) manufactured by Runbio Biotech Co.,Ltd. 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 July 17, 2006. Regulation: 8.