
Zeus Scientific, Inc.
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ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM is an FDA 510(k)-cleared medical device (K113397) manufactured by Zeus Scientific, 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 July 25, 2012. Regulation: 8.