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Phoenix Diagnostics, Inc.
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PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS is an FDA 510(k)-cleared medical device (K020364) manufactured by Phoenix Diagnostics, Inc.. 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 June 3, 2002. Regulation: 8.