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Dade Microscan, Inc.
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MICROSTREP PLUS PANEL, AZITHROMYCIN is an FDA 510(k)-cleared medical device (K021169) manufactured by Dade Microscan, 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 June 5, 2002. Regulation: 8.