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Binax, Inc.
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CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 is an FDA 510(k)-cleared medical device (K091766) manufactured by Binax, 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 February 23, 2010. Regulation: 8.