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Olympus Life Science Research Europa GmbH (Europa)
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OLYMPUS TOTAL BHCG TEST SYSTEN is an FDA 510(k)-cleared medical device (K080094) manufactured by Olympus Life Science Research Europa GmbH (Europa). 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 September 2, 2008. Regulation: 8.