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Alere Scarborough, Inc.
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WOUNDCHEK Bacterial Status is an FDA 510(k)-cleared medical device (DEN180014) manufactured by Alere Scarborough, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2019. Regulation: 8.